Clinical trials: sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Gonorrhea Male, Chlamydia (Male)
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Men who have sex with men (MSM) are at high risk for gonorrhea and chlamydia in Kenya, where nucleic acid amplification testing is not feasible and most infections therefore go undiagnosed.
- Conditions
- Gonorrhea Male, Chlamydia (Male), Syphilis Male
- Trial name
- NCT06468462
- Testing
- WHO-recommended periodic presumptive treatment, Doxycycline post-exposure prophylaxis
- Where
- 3 sites in Kenya
- Volunteers
- 2,900 people, healthy volunteers welcome
- Sponsor
- University of Washington
Pulmonary Tuberculosis
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary…
- Trial name
- RAD-TB (NCT06192160)
- Testing
- Isoniazid, Rifampicin, Pyrazinamide
- Where
- 30 sites in Botswana, Brazil and 12 more
- Volunteers
- 341 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immunodeficiency Disorders
The Mechanistic Biology of Primary Immunodeficiency Disorders
Background: Primary immunodeficiency disorders, or PIDs, are diseases that weaken the immune system. This makes it easier for a person to get sick. Some PIDs are mild and may not be diagnosed until later in life.
- Trial name
- NCT03394053
- Where
- 2 sites in United States
- Volunteers
- 1,190 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Anosmia, Chronic Obstructive Pulmonary Disease
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Background: Exposure to smoke increases the risk of many diseases. People can be exposed to dangerous levels of smoke during wildfires. Also, smoke from fires that burn manmade materials may contain toxic chemicals.
- Conditions
- Anosmia, Chronic Obstructive Pulmonary Disease, Hyposmia, Chronic Rhinosinusitis
- Trial name
- NCT07867184
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cytomegalovirus (CMV), Kidney Transplant; Complications
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR).
- Conditions
- Cytomegalovirus (CMV), Kidney Transplant; Complications, Kidney Diseases
- Trial name
- KPoP (NCT06798909)
- Testing
- Valganciclovir (Pre-emptive CMV Therapy), Valganciclovir CMV Prophylaxis
- Where
- 8 sites in United States
- Volunteers
- 360 people
- Sponsor
- University of California, San Francisco
Tuberculosis
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB).
- Trial name
- NCT07124559
- Testing
- Rifapentine, Isoniazid, Dolutegravir
- Where
- 11 sites in Botswana, Haiti and 4 more
- Volunteers
- 144 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Crohn's Disease
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Background: Crohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition.
- Trial name
- NCT03167437
- Testing
- Vorinostat, Ustekinumab
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV I Infection, Tuberculosis
Evaluating the Safety and Immunogenicity of MTBVAC
The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa
- Trial name
- HVTN605A5421 (NCT05947890)
- Testing
- MTBVAC, BCG
- Where
- 16 sites in South Africa
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
Clostridium Difficile Infection
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
This is a Phase 1, first-in-human, double-blind, placebo-controlled, adaptive-design, single-site study, involving dose exploration cohorts.
- Trial name
- NCT07649096
- Testing
- FZ002
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Filariasis, Helminthiasis
Host Response to Infection and Treatment in Filarial Diseases
This study will evaluate and treat patients with filarial infections to explore in depth the immunology of the disease, including susceptibility to infection, disease development, and response to treatment.
- Conditions
- Filariasis, Helminthiasis, Parasitic Infection, Mansonelliasis
- Trial name
- NCT00001230
- Testing
- Diethylcarbamazine
- Where
- United States
- Volunteers
- 425 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
DOK 8, STAT1
Genetic Analysis of Immune Disorders
The purposes of this study are to 1) identify the genes responsible for certain immune disorders, 2) learn about the medical problems they cause, and 3) learn how to predict who is likely to develop these disorders and what the…
- Conditions
- DOK 8, STAT1, GATA2, Immunodeficiency
- Trial name
- NCT00001467
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults
This Phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of PepGNP-COVID19, a synthetic nanoparticle-based, T cell-priming peptide vaccine against SARS-CoV-2, when administered as a booster dose in…
- Trial name
- NCT07183709
- Testing
- PepGNP-COVID19, Sterile Water for Injection
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Invasive Candidiasis
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
The goal of this clinical trial is to compare antifungal therapy duration in uncomplicated candidemia. The specific aims are: Compare the desirability of outcome ranking in patients with uncomplicated candidemia randomized to 7…
- Trial name
- COUNT (NCT05763251)
- Testing
- therapy duration
- Where
- 22 sites in United States, Australia
- Volunteers
- 420 people
- Sponsor
- Arkansas Children's Hospital Research Institute
Atopic Dermatitis, Eczema
Cardamom and Topical Roseomonas in Atopic Dermatitis
Background: Atopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep…
- Trial name
- NCT06096857
- Testing
- Roseomonas mucosa (RSM2015) and Cardamom seeds
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria,Falciparum, Malaria in Pregnancy
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL)…
- Conditions
- Malaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, Pregnancy
- Trial name
- INTREPiD (NCT05757167)
- Testing
- Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
- Where
- 2 sites in Democratic Republic of the Congo, Kenya
- Volunteers
- 2,174 people
- Sponsor
- Duke University
Malaria
L9LS in Women of Childbearing Potential in Mali
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
- Trial name
- NCT07060508
- Testing
- Single dose of 1800 mg L9LS SC
- Where
- 3 sites in Mali
- Volunteers
- 279 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Anogenital Herpes, COVID-19
Viral Infections in Healthy and Immunocompromised Hosts
Background: Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems.
- Conditions
- Anogenital Herpes, COVID-19, Herpes Labialis
- Trial name
- NCT01306084
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Granulomatous Disease, Infection
NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
Background: CGD is caused by a gene mutation. For people with CGD, their cells cannot kill germs well, so they can get frequent or life-threatening infections.
- Trial name
- NCT05189925
- Testing
- gp91 Grans
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Enterobacteriaceae Infections, Community-Acquired Infections
Community-associated Highly-Resistant Enterobacterales
This is a prospective multi-center study. Bacterial isolates from hospitalized patients with CA-HRE will be compared to those from hospitalized patients with healthcare-associated HRE (HA-HRE).
- Conditions
- Enterobacteriaceae Infections, Community-Acquired Infections, Healthcare Associated Infection, Carbapenem-Resistant Enterobacteriaceae Infection
- Trial name
- COCARE (NCT03924934)
- Where
- United States
- Volunteers
- 2,172 people
- Sponsor
- University of North Carolina, Chapel Hill
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