Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori

Background: Helicobacter pylori is a bacterium that infects the lining of the stomach and intestines. It can cause peptic ulcers, cancers, and infections. Current methods of diagnosing H. pylori infections have limitations. Researchers want to test a new method of testing for H. pylori.

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Office/Contact: Perla Adames Castillo, B.S.N.
Phone: 301-402-8495
Email: perla.adamescastillo@nih.gov
 

Preclinical Models of Infectious Disease Microphysiological Systems

With advances in 3D bioprinting and tissue engineering technologies, the development and use of complex in vitro model systems such as microphysiological systems (MPS) is rapidly growing to study organ function, disease, drug discovery, drug efficacy and toxicology.

NIAID provides preclinical services using human cell-based MPS and organoids to test promising therapeutic candidates that combat viruses of biodefense (pandemic) concern.

As Prevention Strategy for Sexually Transmitted Infections Rolls Out, Experts Highlight both Promise and Knowledge Gaps

DoxyPEP is reducing the rate of syphilis and chlamydia but has had little to no effect on gonorrhea and needs close monitoring for antibiotic resistance.

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Measuring Innovation: Laboratory Infrastructure to Deliver Essential HIV Clinical Trial Results

NIAID Now |

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Credit: NIAID

This blog is the fifth in a series about the future of NIAID's HIV clinical research enterprise. For more information, please visit the HIV Clinical Research Enterprise page.

The outcomes of HIV clinical trials are often determined by precisely and accurately measuring how specific interventions work biologically in people. Whether tracking immune responses to a preventive vaccine candidate, monitoring changes to the amount of virus in the body, or screening for certain adverse events after administering a novel therapeutic, study teams routinely interact with clinical trial participants to safely obtain, store, transport, and analyze tissue and bodily fluid samples to answer important scientific questions about the impact of an HIV intervention in a laboratory. High quality, reliable laboratory infrastructure is critical to the accuracy and validity of clinical trial results. 

More than 150 NIAID-supported laboratories in 20 countries are addressing the diverse scientific programs of the four clinical trials networks in the Institute’s HIV clinical research enterprise. Since the start of HIV clinical research, laboratory capacities have grown in scope to support an increasing number of global clinical trials, emerging complexities in study protocol design and laboratory testing demands and evolving regulatory requirements for research and licensure.

NIAID is engaging research partners, community representatives, and other public health stakeholders in a multidisciplinary evaluation of its HIV clinical trials networks’ progress toward short- and long-term scientific goals. This process assesses knowledge gained since the networks were last awarded in 2020 to identify an essential path forward based on the latest laboratory and clinical evidence. Future NIAID HIV clinical research investments build on the conclusions of these discussions. 

In the next iteration of HIV clinical trials networks, laboratory functions will continue to evolve to align with scientific priorities and research approaches. Networks will support small early-phase trials, large registrational trials and implementation science research to examine preventive vaccine candidates and non-vaccine prevention interventions, antiviral treatments, HIV curative strategies, and therapies to improve the clinical outcomes of people affected by and living with HIV. Selected studies also will rely on high quality laboratory resources to examine interventions for tuberculosis, hepatitis, mpox and other infectious diseases. Clinical trial networks will need to employ a variety of laboratory types to achieve these objectives.  To increase flexibility and ensure the timeliness and the high quality standards the HIV field relies on for evidence that informs science, licensure and equitable practice, NIAID will have the ultimate authority for laboratory selection and approval.

Efficiency and Versatility 

Laboratory assays for HIV clinical trials continue to expand in quantity and complexity and require proportionate technical expertise and management. Future clinical research needs will include immunologic, microbiologic, and molecular testing, as well as standard chemistries and hematologic assays, with fluctuating volumes across a global collection of research sites. Balancing capacity, efficiency, scalability, and cost will require a mixed methods approach. These may include centralized laboratory testing where feasible and advantageous for protocol-specified tests; standardized processes for rapid assessment and approval of new network laboratories; and validated third-party outsourcing of routine assays to ensure timely turnaround when demands surge. 

Quality and Standardization

Ensuring consistent laboratory operations and high quality laboratory data will require continued compliance with the NIAID Division of AIDS Good Clinical Laboratory Practices and other applicable regulatory guidelines, ongoing external quality assurance monitoring, strong inventory management, importation and exportation expertise, and data and specimen management.

The research community plays an essential role in shaping NIAID’s scientific direction and research enterprise operations. We want to hear from you. Please share your questions and comments at NextNIAIDHIVNetworks@mail.nih.gov.

About NIAID’s HIV Clinical Trials Networks

The clinical trials networks are supported through grants from NIAID, with co-funding from and scientific partnerships with NIH’s National Institute of Mental Health, National Institute on Drug Abuse, National Institute on Aging, and other NIH institutes and centers. There are four networks—Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, the HIV Vaccine Trials Network, the HIV Prevention Trials Network, and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network.

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Bacteria, fungi, and other microbes evolve over time and can develop resistance to antimicrobial drugs. Microbes naturally develop resistance; however, using antibiotics too often in humans and animals and in cases where antibiotics are not an appropriate treatment can make resistance develop more quickly.

Antimicrobial resistance is a significant public health problem in the U.S. and around the world as infections are becoming increasingly difficult to treat, especially in healthcare facilities and in people with weakened immune systems.

To address this growing problem, NIAID is funding and conducting research to better understand how microbes develop and pass on resistance genes. NIAID is also supporting the development of new and faster diagnostic tests to make it easier for doctors to prescribe the most effective drug. NIAID’s research program also focuses on ways to prevent infections, including vaccines, and developing new antibiotics and novel treatments effective against drug-resistant microbes.

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Antibacterial Resistance Leadership Group

The Antibacterial Resistance Leadership Group (ARLG) is composed of scientific experts from government agencies, academic institutions, and nonprofit and industry groups around the world. The ARLG oversees a clinical research network that conducts studies on important aspects of antimicrobial resistance, including testing novel therapeutics and diagnostics.

Read more about the ARLG
Antimicrobial Drug Resistance
Antimicrobial Resistance
Page Summary
Bacteria, fungi, and other microbes evolve over time and can develop resistance to antimicrobial drugs. Microbes naturally develop resistance; however, using antibiotics too often in humans and animals and in cases where antibiotics are not an appropriate treatment can make resistance develop more quickly.

Highlights

Two female scientists looking though microscope

NIAID’S Antibiotic Resistance Research Framework: Current Status and Future Directions

This report describes NIAID’s portfolio of basic, translational, and clinical research in AR and outlines an updated array of innovative approaches based on the latest scientific advances and research opportunities to address this urgent public health priority.

Can Improved Tests Speed Up Treatment for Antibacterial Resistant Infections?

An ongoing NIAID-supported trial is testing whether rapid tests for antibiotic susceptibility can improve patient outcomes.

Research Area Type
Disciplines & Approaches

Researchers Explore How Malaria Parasites Evolve Drug Resistance

WVU Scientists Using Nanotechnology to Combat Antibiotic-Resistant Infections

UAMS College of Public Health Researcher Awarded $3.6 Million to Study Antibiotic Resistance

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Article
Publish or Event Date
Link URL
https://news.uams.edu/2024/10/31/uams-college-of-public-health-researcher-awarded-3-6-million-to-study-antibiotic-resistance/
Research Institution
University of Arkansas for Medical Sciences
Short Title
UAMS College of Public Health Researcher Awarded $3.6 Million to Study Antibiotic Resistance
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Claudia Wair
Content Manager
Jennifer Routh

UF Health Researchers Awarded $11.8 Million Grant to Fight Antibiotic-Resistant Bacteria

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Article
Publish or Event Date
Link URL
https://ufhealth.org/news/2024/uf-health-researchers-awarded-11-8-million-grant-to-fight-antibiotic-resistant-bacteria
Research Institution
University of Florida Health
Short Title
UF Health Researchers Awarded $11.8 Million Grant to Fight Antibiotic-Resistant Bacteria
Content Coordinator
Claudia Wair
Content Manager
Jennifer Routh

Collaborate to Defeat Antibiotic-Resistant Bacterial Infections

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The Combating Antibiotic-Resistant Bacteria Interdisciplinary Research Units (CARBIRUs) (P01, Clinical Trial Not Allowed) notice of funding opportunity (NOFO) aims to support multidisciplinary, collaborative research programs focused on discovery to early development research to inform new approaches to prevent, diagnose, and treat antibiotic-resistant bacterial infections. 

Research Scope and Objectives 

This NOFO solicits applications to continue the Combating Antibiotic-Resistant Bacteria Interdisciplinary Research Unit (CARBIRU) program, established in 2021. It is expected that each CARBIRU will conduct highly innovative and synergistic research activities centered on a unifying theme or set of hypotheses to address important gaps in our current knowledge.  

Themes could include, but are not limited to: 

  • Identification of novel strategies to prevent, diagnose, or treat antibiotic-resistant bacterial infections. 
  • Elucidation of mechanisms of antibiotic resistance and strategies to prevent the emergence of resistance. 
  • Understanding antibiotic treatment failure, including the contribution of non-traditional mechanisms of resistance. 
  • Understanding the role of the microbiome and antibiotic-mediated dysbiosis in the development of resistant bacterial infections. 

CARBIRU projects contributing to a unifying theme could include, but are not limited to: 

  • Discovery and functional characterization of bacterial and host factors that are important for infection and antibacterial resistance. 
  • Studies to improve our understanding of genotypic and phenotypic mechanisms of antibiotic resistance and the role they play in resistant infections. 
  • Discovery and validation of novel drug targets and early drug screening. 
  • Characterization and validation of novel antibiotics and non-antibiotic products including, but not limited to, bacteriophage and live microbiome-based products. 
  • Discovery research to enable development of rapid, sensitive, and accurate diagnostics. 
  • Studies to improve our understanding of the host response to eliminate infection and how organisms evade the immune response. 
  • Discovery research and identification of correlates of immune protection to inform vaccines or immunotherapeutics. 
  • Studies on human-associated microbial communities and the role they play in susceptibility or resistance to resistant infections. 
  • Systems-level approaches to identify host and bacterial molecular interactions important for infection and antibacterial resistance. 

Program themes must target one or more of the bacterial pathogens listed below: 

  • Carbapenem-resistant Enterobacterales
  • Extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales
  • Carbapenem-resistant Acinetobacter baumannii
  • Multidrug-resistant (MDR) Pseudomonas aeruginosa
  • Drug-resistant Neisseria gonorrhoeae
  • Methicillin-resistant Staphylococcus aureus (MRSA) 
  • Vancomycin-resistant Enterococci (VRE)
  • Drug-resistant Streptococcus pneumoniae
  • Clostridioides difficile

Applications that do not propose one or more of those bacterial pathogens, or applications with the following proposed studies, will be considered nonresponsive and will not be reviewed: 

  • Targeting mycobacteria or drug-resistant tuberculosis since they are supported by other NIAID programs. 
  • Targeting fungal or viral pathogens. 

Overall CARBIRU Structure 

Each CARBIRU will consist of the following components organized around a common theme or set of hypotheses: an Administrative Core, responsible for conducting program oversight and coordination, monitoring overall progress, and supervising the entire range of the program’s research and administrative responsibilities; a minimum of two and a maximum of four Research Projects organized around a common theme or set of hypotheses; one or a maximum of three Scientific Core(s), which must support the activities of at least two Research Projects; Annual Programmatic Meetings to facilitate communication and collaboration between funded CARBIRUs. 

Application Requirements 

NIAID will fund four to five awards in fiscal year 2026. Application budgets are not expected to exceed $1.5 million in direct costs per year. Project periods are capped at 5 years. 

Applications are due March 26, 2025, by 5:00 p.m. local time of the applicant organization. 

For scientific or research questions, contact Dr. Nancy Lewis Ernst at nancy.ernst@nih.gov or 240-669-5076. Direct questions about peer review to Dr. Marci Scidmore at marci.scidmore@nih.gov, 240-627-3255 or Dr. Mairi Noverr at mairi.noverr@nih.gov, 240-987-1668.

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