Clinical trials: tuberculosis
Tuberculosis
Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans
A nonrandomized, open-label trial will be conducted with a total of 64 healthy male and non-pregnant females, ages 18-45 years. Participants in Group A will enroll 32 participants to receive 2x10^6 colony- forming units CFU…
- Trial name
- NCT06845358
- Testing
- BCG TICE strain, Sodium Chloride, 0.9%, Sterile Water for Injection
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial…
- Trial name
- NCT05592223
- Testing
- BCG Vaccine USP, Isoniazid, Rifampin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Tuberculosis
Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET
This is an observational study that will examine the pretomanid pharmacokinetics (PK) in tuberculosis (TB) patients. Dynamic 18F-pretomanid PET/CT will be performed after intravenous injection of 18F-pretomanid to determine…
- Trial name
- NCT05609552
- Testing
- 18F-Pretomanid PET/CT
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Pregnant HIV Positive Women, HIV
TB SCReening Improves Preventive Therapy Uptake in Pregnant Women With HIV
Because pregnant women have been excluded from clinical research, including tuberculosis (TB) research, little is known about diagnosing, treating and preventing TB in pregnant women.
- Conditions
- Pregnant HIV Positive Women, HIV, Tuberculosis (TB)
- Trial name
- TB SCRIPT-Moms (NCT07278453)
- Testing
- CRP screening (TB screening intervention arm), Deferred TPT (TPT delivery trial intervention arm)
- Where
- Uganda
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
TB - Tuberculosis
Start Taking Action for Tuberculosis in Kids
Start4Kids: Evaluating the performance, feasibility, acceptability and cost effectiveness of computer-aided detection (CAD) of chest X-ray (CXR) and concurrent testing using novel diagnostics and non-sputum specimens for…
- Trial name
- Start4Kids (NCT07248423)
- Testing
- Xpert MTB/RIF Ultra, Truenat, MTB, Truenat MTB Plus
- Volunteers
- 7,920 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Cough, COPD
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
This study pretends to evaluate the potential use of Hyfe Cough Tracker (Hyfe) to screen for, diagnose, and support the clinical management of patients with respiratory diseases, while enriching a dataset of disease-specific…
- Conditions
- Cough, COPD, GERD, Asthma
- Trial name
- NCT05042063
- Testing
- Hyfe Cough Tracker, Hyfe Air
- Where
- Spain
- Volunteers
- 616 people, healthy volunteers welcome
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Pulmonary Tuberculosis, Tuberculosis
ATORvastatin in Pulmonary TUBerculosis
Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally. According to recent estimates from the World Health Organization (WHO), over 10 million new cases and 1.6…
- Conditions
- Pulmonary Tuberculosis, Tuberculosis, Koch's Disease
- Trial name
- ATORTUB (NCT06199921)
- Testing
- Atorvastatin 20mg, Atorvastatin 40mg, Atorvastatin 60mg
- Where
- 8 sites in Nigeria
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Obafemi Awolowo University Teaching Hospital
Tuberculosis
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
According to WHO, about 40% of the incident TB cases in 2020 are either under-reported or under-diagnosed causing on one hand major health risks and on the other hand catastrophic financial consequences.
- Trial name
- NCT05526885
- Testing
- CAD4TB, POC-CRP, Xpert MTB/RIF Ultra
- Where
- 2 sites in Lesotho, South Africa
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Klaus Reither
Pulmonary Tuberculosis, Hypoalbuminemia
I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis
This study evaluates the potential of I-FALMIN, a supplement derived from toman fish (Channa micropeltes), as an additional source of albumin in patients with pulmonary tuberculosis.
- Trial name
- I-FALMIN TB (NCT07186478)
- Testing
- Investigational Drug
- Where
- Indonesia
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Hasanuddin University
Tuberculosis
Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above
This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above.
- Trial name
- NCT07152639
- Testing
- 5μg/ml EEC, 5 unit（U） EC, 5 IU TB-PPD
- Where
- 8 sites in China
- Volunteers
- 1,784 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Tuberculosis
A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age
The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on…
- Trial name
- NCT06354257
- Testing
- Microgynon, GSK3036656
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnancy, Neonatal Mortality
Scalable Public Health Empowerment, Research, and Education Sites (SPHERES)
SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model.
- Conditions
- Pregnancy, Neonatal Mortality, Tuberculosis, Hepatitis B
- Trial name
- SPHERES (NCT07126041)
- Testing
- Prescription for Action (SPHERES Model)
- Where
- 2 sites in Indonesia
- Volunteers
- 1,750,000 people, healthy volunteers welcome
- Sponsor
- Oxford University Clinical Research Unit Indonesia
Tuberculosis
Evaluation of CAD-based Triage for CXR Interpretation During TB Screening
Clinical workflows which position computer-aided detection (CAD) software for chest X-ray interpretation during TB screening as a decision support tool for radiologists, with the aim of improving interpretation accuracy and/or…
- Trial name
- NCT06401434
- Testing
- On-site radiologist, CAD-based triage (with INSIGHT CXR software)
- Where
- 3 sites in Vietnam
- Volunteers
- 23,835 people, healthy volunteers welcome
- Sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.V
Tuberculosis, Pulmonary, HIV Coinfection
Pharmacist-Led Intervention to Improve TB Treatment Adherence
The goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group The main question[s]it aims to answer are: 1.
- Trial name
- RA-15041995 (NCT06608069)
- Testing
- Educational counselling
- Where
- 2 sites in Malaysia
- Volunteers
- 383 people, healthy volunteers welcome
- Sponsor
- Universiti Sains Malaysia
Tuberculosis (TB)
Tuberculosis (TB) Aftermath
TB Aftermath will compare effectiveness, cost-effectiveness and feasibility of two ACF strategies for detecting recurrent TB and provide evidence needed to implement and scale the preferred ACF strategy.
- Trial name
- NCT04333485
- Testing
- Home-based Active Case Finding (HACF), Telephonic Active Case Finding (TACF)
- Where
- India
- Volunteers
- 3,094 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Diabetes Mellitus, Latent Tuberculosis Infection
Prospective Quality Improvement Project for High-Risk Diabetes Patients
Diabetes is the most important comorbidity of tuberculosis patients in Taiwan, and 1/4 of tuberculosis patients also It is a diabetic patient, and the treatment of latent tuberculosis infection is currently an important policy of…
- Conditions
- Diabetes Mellitus, Latent Tuberculosis Infection, Continuous Glucose Monitoring, Quality of Life
- Trial name
- NCT06472609
- Testing
- enhanced interactive education
- Where
- Taiwan
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University WanFang Hospital
Tuberculosis
Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus…
- Trial name
- NCT04152161
- Testing
- BCG vaccine SSI
- Where
- 5 sites in South Africa
- Volunteers
- 1,836 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Tuberculosis, Pulmonary
ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74
The purpose of this study is to evaluate the safety and explore the immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in the Bacillus Calmette-Guérin…
- Trial name
- NCT06714513
- Testing
- QTP101
- Where
- 4 sites in South Korea
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
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)
Tuberculosis
Pretomanid in Adults With Hepatic Impairment
This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects.
- Trial name
- NCT02422524
- Testing
- PA-824
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)