University of South Florida researchers secure $1.5 million federal grant for unique new system to reduce water pollution

First-of-its-kind approach can be replicated elsewhere to provide more efficient filtration, protect marine environments

Grant and Award Announcement

UNIVERSITY OF SOUTH FLORIDA

 

IMAGE: AARAN'S POND, IN TAMPA, FLA., WHERE USF RESEARCHERS ARE TESTING A FIRST-OF-ITS-KIND FILTRATION SYSTEM TO REMOVE POLLUTANTS AND CAPTURE NUTRIENTS FROM STORMWATER RUNOFF. view more 

CREDIT: UNIVERSITY OF SOUTH FLORIDA

TAMPA, Fla. (Sept. 21, 2023) - An interdisciplinary team of researchers from the University of South Florida is working to protect the environment by preventing pollution from seeping into a local stormwater pond that flows into Tampa Bay and the Gulf of Mexico.

Through a three-year, $1.5 million grant from the U.S. Environmental Protection Agency, the team is installing a bio-infiltration system at Aaran’s Pond in Tampa’s University Area Community, where more than one in three residents live below the federal poverty level.

According to principal investigator Professor Sarina Ergas in the USF Department of Civil and Environmental Engineering, when it rains, the water washes pollutants, such as fertilizer, oil, animal waste and rotting vegetation into gutters, which then feed into an existing stormwater pond. For that reason, urban runoff is a challenging problem to address in underserved communities, especially as stormwater ponds are often full of trash and difficult to clean due to restrictive fencing and steep slopes.

“We’re calling them inert zombies due to their lack of life,” Ergas said. “If you look at the difference between a stormwater pond in a wealthy neighborhood and one in a low-income neighborhood – it’s day and night in terms of how they benefit the community.”

If those pollutants are not removed from the ponds, they eventually cascade into the Hillsborough River and Tampa Bay, which feeds into the Gulf of Mexico. Nutrients, such as nitrogen, create harmful algal blooms, kill sea grass and reduce oxygen in the water.

The team is partnering with Oldcastle Infrastructure to install four new bio-infiltration systems around the pond to improve the nutrient removal. The systems will retain and treat the runoff water with biochar, a charcoal-like material that will help reduce the nutrient pollution and increase microbial activity and plant growth.

Previous studies with biochar have taken place in the lab, making this the first time it’s used in a pond to improve water quality.

The USF team is collaborating with Mary Lusk, a University of Florida expert in stormwater ponds and their functions, to redesign the pond with the Hillsborough County Engineering and Operations Department. The plan is to plant bio-infiltration systems with shrubs and bushes along the steep slopes to provide additional filtration and make the pond more visually appealing.

“We strongly believe the efforts undertaken by this project, along with our collaboration in its implementation, will result in positive, long-term benefits for our community,” said Sarah Combs, chief executive officer of the University Area Community Development Corp., which focuses on the redevelopment and sustainability of at-risk areas surrounding the USF Tampa campus. “As partners, we share in the goal of leveraging resources to improve human and environmental health and the social well-being of residents who live in the community.”

Christian Wells, professor in the Department of Anthropology, described the project as “an opportunity to reimagine what stormwater ponds can do for communities.”

With help from graduate students, Wells will survey nearby residents to develop strategies that respond to the needs of the community. The information will be used to enhance recreational opportunities and improve the residents’ access to green space with new features, such as picnic tables, walking trails and a park.

To view this story on the USF Newsroom website, click here. 

USF researcher Christian Wells at Aaran's Pond in Tampa, Fla.

About the University of South Florida

The University of South Florida, a high-impact research university dedicated to student success and committed to community engagement, generates an annual economic impact of more than $6 billion. With campuses in Tampa, St. Petersburg and Sarasota-Manatee, USF serves approximately 50,000 students who represent nearly 150 different countries. U.S. News & World Report has ranked USF as one of the nation’s top 50 public universities for five consecutive years, and this year USF earned its highest ranking ever among all universities public or private. In 2023, USF became the first public university in Florida in nearly 40 years to be invited to join the Association of American Universities, a prestigious group of the leading universities in the United States and Canada. Through hundreds of millions of dollars in research activity each year and as one of the top universities in the world for securing new patents, USF is a leader in solving global problems and improving lives. USF is a member of the American Athletic Conference. Learn more at www.usf.edu.

 

Study finds most caregivers of cancer patients are not screened for distress

Peer-Reviewed Publication

ATRIUM HEALTH WAKE FOREST BAPTIST

 

IMAGE: CHANDYLEN NIGHTINGALE, PH.D., ASSISTANT PROFESSOR OF SOCIAL SCIENCES AND HEALTH POLICY AT WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE view more 

CREDIT: WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE

WINSTON-SALEM, N.C. – Sept. 21, 2023 – Being diagnosed with a serious illness such as cancer brings many physical, emotional and financial burdens, not only for patients, but for their caregivers as well.  However, a new study from researchers at Wake Forest University School of Medicine shows that caregivers of adult cancer patients are often overlooked in cancer care.

The study was published online today in the Journal of the National Cancer Institute.

“The role of the caregiver is incredibly important, but it’s also very challenging,” said Chandylen Nightingale, Ph.D., assistant professor of social sciences and health policy at Wake Forest University School of Medicine and co-principal investigator of the study. “Caregiver well-being is crucial because there is evidence to suggest that happy and healthy caregivers provide better support and care to their loved ones, potentially leading to better patient outcomes and even reduced burden for our health care systems.”

For the observational study, the research team collected data in collaboration with the National Cancer Institute Community Oncology Research Program (NCORP).

Supportive care leaders at the NCORP sites completed online survey questions related to caregivers, distress screening and distress management strategies at their oncology practices.

“We found that 92.5% of practices screen patients for distress. However, only 16% routinely screen caregivers,” Nightingale said.

The research team also looked at the number of sites that not only identified caregivers but also screened them and had referral strategies in place for those who screened positive.

“When we looked at the sites that were comprehensively doing all of that, it was less than 13%,” Nightingale said. “When we analyzed the same for patients—screening and referral resources—we found that 90.6% of the sites were doing that.”

According to Nightingale, distress screening for caregivers doesn’t have to be a complex process. Oncology practices could implement a single-item distress thermometer, which is one question on a scale of 0 to 10.

“We do need to better understand the unique barriers in community oncology settings that are preventing systematic screening for caregivers,” Nightingale said. “Our findings suggest that patient distress screening is widespread among community oncology clinics. However, very few are comprehensively engaging caregivers.”

NCORP is a national network that brings cancer clinical trials and care delivery studies to communities. The Wake Forest NCORP Research Base at Atrium Health Wake Forest Baptist’s National Cancer Institute-designated Comprehensive Cancer Center is one of seven funded NCORP Research Program bases in the country.

“Defeating cancer is a team effort, and I commend Dr. Nightingale and the entire team for looking at such an important issue,” said Ruben Mesa, M.D., president of Atrium Health Levine Cancer, executive director of Wake Forest Baptist’s Comprehensive Cancer Center and vice dean for cancer programs at Wake Forest University School of Medicine. “The hope is that we can leverage existing processes for patients and translate them to caregivers to make sure we are providing the best possible support for patients across the country who are facing cancer.”

Going forward, the research team aims to have a better understanding of the barriers that prevent caregiver screening and how to make supportive care services more accessible.

Katherine R. Sterba, Ph.D., professor of public health sciences at Medical University of South Carolina College of Medicine in Charleston, S.C. is a co-principal investigator of the study.

The study work was supported by the National Cancer Institute (Wake Forest NCORP Research Base 5UG1CA189824).

---

JOURNAL

JNCI Journal of the National Cancer Institute

DOI

10.1093/jnci/djad198 

METHOD OF RESEARCH

Observational study

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Processes for Identifying Caregivers and Screening for Caregiver and Patient Distress in Community Oncology: Results from WF-1803CD

ARTICLE PUBLICATION DATE

21-Sep-2023

 

The Mount Sinai Hospital commemorates 75th anniversary of first dialysis procedure with continuing medical education event

The Dialysis Odyssey celebrates research advancements changing practice and improving lives of patients today

Meeting Announcement

THE MOUNT SINAI HOSPITAL / MOUNT SINAI SCHOOL OF MEDICINE

New York, NY (September 21, 2023) –Seventy-five years after pioneering doctors at The Mount Sinai Hospital conducted the first hemodialysis treatment in the United States, the hospital is marking progress to date in a continuing medical education (CME) event on Monday, October 2. The event will be led by innovators in the field of nephrology who are exploring advancements and innovations for a growing population of adults requiring dialysis. Additional details about the course, still open for registration, can be found online. 

 

The one-day, in-person event will feature expert clinicians and researchers in the field of kidney disease who will discuss a variety of topics on the history, evolving ethics, developing treatments, and future of dialysis. Plenary sessions will be followed by a Q&A session. There will also be a dialysis history exhibit in Mount Sinai’s Guggenheim Pavilion, which will be open to attendees prior to the symposium. The event is primarily targeted to nephrologists, urologists, internists, physician assistants, nurses, and students. Physicians can earn up to 3.50 AMA PRA Category 1 Credits™.

The event will:

 

• Review the history of the end-stage renal disease.
• Summarize the developments in kidney replacement therapies over the last 75 years and their impact on patient care and outcomes
• Recognize the challenges associated with the ongoing transition to value-based payment and its impact on access and quality of care
• Identify challenges in delivering kidney replacement therapy in 2023, and review advances as well as limitations of current interventions and the therapies of tomorrow
• Discuss current and future trends in the management of patients requiring renal replacement therapy

 

Kidney diseases are a leading cause of death in the United States and result primarily from diabetes and high blood pressure. Chronic kidney disease affects an estimated 15 percent of Americans, says the Centers for Disease Control and Prevention (CDC).

 

Hemodialysis represents one of the most effective treatments for advanced kidney failure for patients whose kidneys can no longer filter wastes, salts, and fluid from the blood. Course director and moderator Jaime Uribarri, MD, Professor of Medicine (Nephrology) at the Icahn School of Medicine at Mount Sinai, directs The Mount Sinai Hospital’s Home Dialysis Program, one of the largest in New York City. He says Icahn Mount Sinai’s Renal Division has been intensively studying and assessing potential therapies to slow progression to end-stage renal disease. While much progress has been made during the past several decades, maintenance of an open vascular access continues to challenge nephrologists today.

 

Dr. Uribarri credits his colleague Evren Azeloglu, PhD, Associate Professor of Medicine (Nephrology), and Pharmacological Sciences, and a team of researchers for inventing a new implantable vascular access port. “This new port will be a game changer for our patients as it reduces pain and discomfort and allows easy self-cannulation, enabling safe home hemodialysis. We are currently fine-tuning the device and hope to offer this improvement within several years,” says Dr. Uribarri.

 

In addition to this work, Lili Chan, MD, Associate Professor of Medicine (Nephrology, and General Internal Medicine), at Icahn Mount Sinai, has been focused on an artificial intelligence-driven solution to cull electronic health records. This innovation will help identify unmet social determinants of health commonly associated with adverse clinical outcomes. “This will improve and facilitate surveillance of our patient population in New York City and facilitate the optimization of treatment and symptom management. Furthermore, it underlines a major priority of bringing an equity lens to our care,” says Dr. Uribarri.

 

Helpful links:

Online registration

A historic review of 75 years of hemodialysis

 

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About the Icahn School of Medicine at Mount Sinai

The Icahn School of Medicine at Mount Sinai is internationally renowned for its outstanding research, educational, and clinical care programs. It is the sole academic partner for the

eight member hospitals* of the Mount Sinai Health System, one of the largest academic health systems in the United States, providing care to a large and diverse patient population. 

Ranked No. 14 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges, Icahn Mount Sinai has a talented, productive, and successful faculty. More than 3,000 full-time scientists, educators, and clinicians work within and across 34 academic departments and 44 multidisciplinary institutes, a structure that facilitates tremendous collaboration and synergy. Our emphasis on translational research and therapeutics is evident in such diverse areas as genomics/big data, virology, neuroscience, cardiology, geriatrics, and gastrointestinal and liver diseases.

Icahn Mount Sinai offers highly competitive MD, PhD, and master’s degree programs, with current enrollment of approximately 1,300 students. It has the largest graduate medical education program in the country, with more than 2,600 clinical residents and fellows training throughout the Health System. In addition, more than 535 postdoctoral research fellows are in training within the Health System.

A culture of innovation and discovery permeates every Icahn Mount Sinai program. Mount Sinai’s technology transfer office, one of the largest in the country, partners with faculty and trainees to pursue optimal commercialization of intellectual property to ensure that Mount Sinai discoveries and innovations translate into health care products and services that benefit the public.

Icahn Mount Sinai’s commitment to breakthrough science and clinical care is enhanced by academic affiliations that supplement and complement the School’s programs. Through Mount Sinai Innovation Partners (MSIP), the Health System facilitates the real-world application and commercialization of medical breakthroughs made at Mount Sinai. Additionally, MSIP develops research partnerships with industry leaders such as Merck & Co., AstraZeneca, Novo Nordisk, and others.

The Icahn School of Medicine at Mount Sinai is located in New York City on the border between the Upper East Side and East Harlem, and classroom teaching takes place on a campus facing Central Park. Icahn Mount Sinai’s location offers many opportunities to interact with and care for diverse communities. Learning extends well beyond the borders of our physical campus, to the eight hospitals of the Mount Sinai Health System, our academic affiliates, and globally.

-------------------------------------------------------

* Mount Sinai Health System member hospitals: The Mount Sinai Hospital; Mount Sinai Beth Israel; Mount Sinai Brooklyn; Mount Sinai Morningside; Mount Sinai Queens; Mount Sinai South Nassau; Mount Sinai West; and New York Eye and Ear Infirmary of Mount Sinai.

 

SCI-FI-TEK

Warming up! 30 years of fusion-energy research at EPFL

EPFL started up a variable-configuration tokamak reactor in 1992. Today, EPFL is a leading research institute in nuclear fusion, with the goal of replicating on Earth the reactions taking place in the stars.

Business Announcement

ECOLE POLYTECHNIQUE FÉDÉRALE DE LAUSANNE

 

IMAGE: INSIDE THE CHAMBER OF EPFL'S TCV (VARIABLE-CONFIGURATION TOKAMAK) view more 

CREDIT: EPFL / ALAIN HERZOG

The intense heat and pressure inside stars, such as the Sun, cause pairs of atoms, especially hydrogen atoms, to come together or 'fuse'. When these light nuclei merge into a heavier nucleus, some mass gets lost and is converted into a massive amount of energy, following Einstein's famous formula, E=mc2. This fusion process is what powers stars and releases an incredible amount of energy into the universe.

Scientists are already able to produce nuclear fusion reactions on Earth. The current challenge faced by researchers around the world is to sustain these fusion reactions continuously and harness the energy released in an efficient and controlled manner to generate electricity. At EPFL, the engineers have chosen to study a method that involves using a torus-shaped magnetic confinement reactor, called a tokamak. In this approach, deuterium gas, a hydrogen isotope, is heated to 100 million degrees Celsius to transform it into a plasma and induce highly energetic collisions between the deuterium nuclei. The tokamak's magnetic fields suspend the plasma in the middle of the vacuum chamber and away from the interior wall of the device.

The Swiss Plasma Center, now with a staff of about 200 researchers and students, started up its own variable-configuration tokamak 30 years ago. Owing to its unique design, this experimental reactor has become one of the most important nuclear-fusion research facilities in Europe.

“We built the reactor even before there was the internet, and its core is still the same,” says Basil Duval, a senior scientist working on the tokamak’s measurement systems. He points out that the research being carried out at the Swiss Plasma Center is known internationally – partly because of its contribution to the International Thermonuclear Experimental Reactor (ITER) project, and partly because the findings are of value to the entire nuclear-fusion research community. “For a country the size of Switzerland to have an experimental facility of this caliber is really outstanding,” says Duval.

To commemorate the 30th anniversary of its tokamak, the Swiss Plasma will host representatives of the EUROfusion consortium in September. This consortium is behind a number of nuclear-fusion initiatives, including advancing the ITER physics basis and optimizing its chances of success via experimentation on facilities such as the TCV tokamak. Ambrogio Fasoli, director of the Swiss Plasma Center, is also the chair of EUROfusion and has just been named the consortium’s programme manager. “Our work at the Swiss Plasma Center over the past 30 years has provided key insights into plasma behavior. The TCV plays a vital role in this endeavor. Recent upgrades to its infrastructure have expanded our capability to investigate key issues for ITER, DEMO, and future fusion reactors. The challenges ahead are substantial, but we are well-positioned to make significant contributions to the development of fusion energy as a critical component of the future global energy mix,” he says.

A unique approach

Because EPFL’s tokamak is a “variable configuration” reactor, scientists can use it to observe how changes in plasma configuration affect the plasma’s properties (like temperature and confinement quality) and study new plasma configurations. It can also be used to evaluate different configurations for divertors, the devices used to control the release of energy from the reactor core. Their role is essential for being able to sustain plasma for long periods without damaging the reactor, and engineers are still working to optimize their design. The Swiss Plasma Center recently teamed up with Google DeepMind to develop a new magnetic control method for plasmas, based on deep reinforcement learning, and successfully applied it to real-world plasma configurations in the TCV tokamak for the first time.

Like all tokamaks, the EPFL's tokamak features a vacuum chamber where gas is transformed into plasma. This chamber is encompassed by toroidal (torus-shaped) magnetic fields, created by large magnetic coils, that prevent the plasma from touching the interior wall of the chamber. Additionally, there is a central column with ohmic coils that maintain plasma stability, and a poloidal field that shapes the plasma configuration. The entire reactor is outfitted with a heating system that utilizes microwaves and hot-particle injection, complemented by a comprehensive array of instruments that measure temperature, density, radiation, fluctuations in plasma configuration, and other vital parameters.

In future fusion power plants, the heat generated by fusion reactions within the plasma will power turbines-similar to current nuclear fission reactors-and produce substantial amounts of dependable baseload electricity. This process will be sustainable and carbon-free, without generating long-lasting radioactive waste.

 

Learn more at: https://spc.epfl.ch

 

NIH center grant bolsters male contraceptive research

NOT HAPPY UNTIL ITS 100% SAFE

MEN ARE SNOWFLAKES

Grant and Award Announcement

WEILL CORNELL MEDICINE

Weill Cornell Medicine has received a three-year, nearly $6 million grant to lead one of three national contraceptive research centers. The grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health, will fund the Weill Cornell Medicine Contraception Development Research Center. Led by Drs. Jochen Buck and Lonny Levin, both professors of pharmacology at Weill Cornell Medicine, the center will focus on developing an on-demand male contraceptive.

“It’s an honor to be selected for a second time for this award,” Dr. Levin said. “It will help us take the next steps in the years-long process of bringing a new contraceptive option to the public.”

Currently, females have many contraceptive options available to them, including taking hormonal pills or having an intrauterine device inserted, though they are often poorly tolerated or inconvenient. The only male contraceptive options are condoms or vasectomies. But a study published by Dr. Buck and Levin earlier this year in Nature Communications demonstrated that a single dose of a drug candidate that inhibits an enzyme called soluble adenylyl cyclase (sAC) immobilizes sperm for up to two and a half hours and prevents pregnancy in mice.

“Our idea is to develop a new form of on-demand contraception,” Dr. Buck explained. “The man takes the pill a half hour before having sex and then will be protected from impregnating someone for eight to twelve hours. Afterwards his fertility returns to normal.”

The funding from the Contraceptive Development Research Center Program at NICHD will help support three distinct projects to advance progress toward developing sAC inhibitor-based male contraceptives and an administrator to oversee the work.

One project will focus on improving the current drug candidate to make it suitable for humans. This candidate was developed and tested in a preclinical model in collaboration with the Sanders Tri-Institutional Therapeutics Discovery Institute (TDI), a relationship fostered by the Weill Cornell Medicine Enterprise Innovation office. The Sanders Tri-I TDI, led by Dr. Peter Meinke, works with investigators from Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center and The Rockefeller University to expedite early-stage drug discovery.

The second project will focus on developing additional compounds that have similar contraceptive effects. The third project will help the center test its compounds in a second preclinical model that more closely mimics human reproduction.

“We want to ensure that we’re starting with the best possible compound before we embark on clinical trials,” Dr. Levin said.

Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosures public to ensure transparency. For this information, see profiles for Dr. Levin and Dr. Buck.

The grant reported in this newsroom story was awarded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development under the Contraceptive Development and Research Center Program, federal award number P50HD113015-01.  

 

New strategies reduce treatment failure in malaria by up to 81%

Peer-Reviewed Publication

PENN STATE

UNIVERSITY PARK, Pa. — Artemisinin-based combination therapies (ACTs) are the globally-accepted first-line treatments for malaria — a mosquito-borne disease caused by the Plasmodium falciparum parasite that annually kills around 600,000 people, mostly children. Yet resistance to ACTs by P. falciparum has emerged in recent years in Africa, threatening their effectiveness.

To slow this resistance and reduce treatment failures, an international research team led by Penn State investigated various drug policy interventions in Rwanda, where artemisinin resistance was first reported in 2020. Among other strategies, the team found that next-generation interventions such as triple ACTs (TACTs) — which combine an artemisinin derivative with two partner drugs or which use a sequential course of one ACT formulation, followed by a different ACT formulation — resulted in treatment failure counts that were at least 81% lower. Their results were published today (Sept. 21) in Nature Medicine.

“The malaria drug-resistance situation in Rwanda is urgent,” said Robert Zupko assistant research professor of biology, Penn State. “If we let things continue as is, artemisinin-resistant genotypes will begin to dominate by the end of this decade. Of the two dozen interventions we evaluated, we found that TACTs — a treatment yet to be approved to treat malaria but undergoing clinical evaluations — was projected to minimize both treatment failures and drug resistance.”

Dr. Aline Uwimana, head of case management at the Rwanda Biomedical Center and a senior author on the study, cautioned that waiting for optimal therapies may not be the best approach as resistance could soon be widespread.

“Of the available and approved approaches that we evaluated for this study, there were several options using multiple first-line therapies, or MFT, that we could begin to put into place next year,” Uwimama said. “This is likely the most feasible choice in the near term.” 

Under an MFT strategy, multiple therapies are deployed at once and different patients get treated with different drugs.

According to Maciej Boni, professor of biology, Penn State, the current situation in Rwanda is a repeat or “three-peat” of past malaria drug failures. Since the 1940s, multiple antimalarial drugs have been deployed worldwide, but the eventual development of drug resistance in the malaria parasite forced the withdrawal of all of them. In the 1990s, new artemisinin drugs were trialed and found to be effective, and by 2005 they were recommended worldwide, he said. The following year, Rwanda adopted the ACT artemether-lumefantrine (AL) as its first-line therapy for malaria, but by 2020, a mutation, known as ‘pfkelch13 R561H’, was shown to have emerged over the previous decade; the R561H mutation is associated with delayed clearance of the parasite in the presence of AL.

“Studies indicate that the pfkelch13 R561H mutation is increasing, but there still may be a window of opportunity to delay its spread and avert high numbers of treatment failures,” Boni said. “The World Health Organization has recommended that the Rwandan National Malaria Control Program begin considering strategies for mitigating the spread of pfkelch13 R561H.”

To address this recommendation, Zupko and Boni worked with the Rwandan National Malaria Control Program and the Rwanda Biomedical Centre to develop plans for slowing down the spread of artemisinin resistance in Rwanda. Specifically, they examined a range of possible drug policy interventions and their ability to reduce long-term treatment failures. These included replacing AL as the first-line therapy with another artemisinin drug, introducing multiple drugs to be used in combination and lengthening the dosing schedule for AL from a three-day course of treatment to up to a five-day course of treatment. Additionally, the researchers evaluated sequential therapy approaches — in which one drug is given for a period of time followed by another — and triple artemisinin combination therapies.

The team modeled the impacts of these strategies on projected treatment failures and the frequency of the R561H mutation within the Plasmodium genome three, five and ten years into the future.

“We found that lengthening courses of treatment, deploying multiple drugs and implementing custom rotation strategies all provide a benefit when compared to the currently recommended three-day course of AL,” Zupko said.

Specifically, the researchers found that extending the use of AL from three to five days and using multiple drugs simultaneously are two strategies that may hold treatment failure rates at or near 10%.

In another study, which was published on July 29 in Nature Communications, the team looked more closely at triple artemisinin combination therapies (TACTs) in general African malaria settings. This work was done by two teams independently – the Penn State team and a University of Oxford modeling team led by associate professor Ricardo Aguas – to ensure that the results were not strongly influenced by the build and design of a single model.

“TACTs have been shown in clinical trials to be effective and well tolerated by patients, and the fact that early TACT adoption may delay the emergence and spread of antimalarial drug resistance is a modeling result of vital importance,” Boni said.

Zupko noted that the results of the research underscore what is already known from historical experience — drug resistance can spread rapidly once it is established.

“It is important to quickly implement an antimalarial policy that contains the spread of artemisinin resistance, including the immediate introduction of TACTs,” he said.

Other Penn State authors on the paper include Tran Dang Nguyen, assistant research professor of biology; Thu Nguyen-Anh Tran, graduate student in biology; and Kien Trung Tran, postdoctoral scholar in biology. Others from the Rwanda Biomedical Centre include J. Claude S. Ngabonziza, division manager; Michee Kabera, director of epidemiology; and Aline Uwimana, director of case management. Haojun Li, recent Penn State graduate and current Columbia University graduate student, also is an author.

The National Institutes of Health and Bill and Melinda Gates Foundation supported this research.

---

JOURNAL

Nature Medicine

DOI

10.1038/s41591-023-02551-w 

 

University of Pittsburgh launches trial tackling leading cause of death in kids

Business Announcement

UNIVERSITY OF PITTSBURGH

 

IMAGE: PHILIP SPINELLA, M.D., CO-DIRECTOR OF THE TRAUMA AND TRANSFUSION MEDICINE RESEARCH CENTER (TTMRC) IN THE DEPARTMENT OF SURGERY AT THE UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE AND AND PROFESSOR OF SURGERY AND CRITICAL CARE MEDICINE AT THE UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE. view more 

CREDIT: UNIVERSITY OF PITTSBURGH

The No. 1 cause of death in children is trauma. There are an estimated 2,000 pediatric deaths from traumatic bleeding in the U.S. each year that are preventable with optimal care, yet there have been no large-scale clinical trials to guide the best way to resuscitate children with life-threatening bleeding from traumatic injury.

Until now.

The Trauma and Transfusion Medicine Research Center (TTMRC) in the Department of Surgery at the University of Pittsburgh School of Medicine is launching a clinical trial to simultaneously test multiple interventions for life-threatening bleeding in at least 1,000 traumatically injured children across 20 U.S. pediatric trauma centers. Funded by the Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health & Human Service, the trial has a budget of $34 million for the first five years, with the possibility to increase to more than $81 million.

“This trial will be transformative when it comes to trauma care for children,” said trial co-principal investigator Philip Spinella, M.D., co-director of the TTMRC and professor of surgery and critical care medicine at Pitt. “Not only is trauma the leading cause of death in kids, their mortality rate with life-threatening bleeding is almost twice that of adults. And we think that’s because of delay in recognition and treatment, not that children are less resilient.”

The Massive Transfusion in Children-II (MATIC-II) is the first randomized trial to use an approach known as a “platform trial” in traumatically injured children or adults. Typical trials compare only one intervention to standard care, but, in practice, doctors give multiple therapies and drugs at the same time. Platform trials test multiple therapies at once against standard of care, which allows scientists to determine which bundle of care is most effective and safe. Platform trials also allow scientists to change the study interventions based on data collected during the trial. A platform trial can adapt to either add or remove treatments to determine the bundle of care that best improves outcomes.

“Pediatric trauma research is decades behind trauma research in adults,” said trial co-principal investigator Christine Leeper, M.D., assistant professor of surgery and critical care medicine at Pitt and trauma surgeon and intensivist at UPMC. “In the time it takes to run a traditional trial, new therapies are introduced while others fall out of favor, so the platform design of MATIC-II will ensure the newest and best therapies are put into practice quickly in order to save lives and help close this knowledge gap.”

When blood is donated, it is typically divided into three parts: red blood cells, platelets and plasma. Patients experiencing massive bleeding usually need all of those components, so clinicians have to put the blood back together – and that reassembly can dilute the products and make them less effective. Research is increasingly indicating that “whole blood” – blood that was never divided into components after donation – may improve survival and reduce the total amount of blood needed in patients with life-threatening traumatic bleeding.

MATIC-II will study the efficacy and safety of whole blood, individual blood components and tranexamic acid, which promotes clotting to stop bleeding, compared with a placebo in newborns up to 18-year-olds with trauma and life-threatening bleeding. Four combinations – tranexamic acid with whole blood, whole blood with a placebo, component blood with a placebo and component blood with tranexamic acid – will be tested, with each of the 20 participating children’s hospitals rotating through the combinations throughout the trial. Each of these therapies are used clinically in children with trauma and life-threatening bleeding, but they haven’t been tested either in isolation or as combination therapy.

The trial will compare all the combinations to determine which one results in the best patient survival after 24 hours and 28 days. The scientists also will do additional studies to better understand a condition known as trauma-induced coagulopathy, which occurs when the blood fails to properly clot. With Angelo D’Alessandro, Ph.D., professor of biochemistry and molecular genetics at the University of Colorado, the team will determine if there are differences in how the children respond to the interventions.  This will form the basis for developing a precision transfusion medicine approach to hemorrhagic shock in children.

“I’m particularly excited about the studies we have planned with Dr. D’Alessandro,” said Spinella. “Just like all cancers aren’t the same, all traumas aren’t the same. Different people and types of trauma respond differently to treatments due to biological factors that we could potentially address to improve outcomes.”

Because emergency trauma care cannot be paused for parents to consent for their children to be in the trial, MATIC-II will have an exception from informed consent protocol that has been approved by an ethics board and the U.S. Food & Drug Administration. Patients will be given the trial treatment, and, once the child is stabilized, the parents will be informed about the trial and their questions will be answered. Parents can then decide whether to give permission for continued participation or remove their child from the trial. Parents can also opt out of having their child in the trial by requesting a special bracelet that will alert emergency clinicians not to use the trial protocol. More information on that will be made available to the public by the investigators before the trial starts.  

This project has been funded in whole with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00047.

The Massive Transfusion in Children-II (MATIC-II) is the first randomized trial to use an approach known as a “platform trial” in traumatically injured children or adults.

CREDIT

University of Pittsburgh

Christine Leeper, M.D., assistant professor of surgery and critical care medicine at the University of Pittsburgh School of Medicine and trauma surgeon and intensivist at UPMC

CREDIT

UPMC