Clinical trials: Mycobacterium Infections
Tuberculosis, HIV/AIDS
TB Reduction Through ART and TB Screening Project
Tuberculosis (TB) has overtaken HIV as the leading infectious cause of death worldwide and requires a major policy shift for it to be controlled in line with the WHO Stop-TB goal to "end TB".
- Trial name
- TREATS (NCT03739736)
- Testing
- Combination of TB/HIV prevention activities (arm A), Combination of TB/HIV prevention activities (arm B), Standard of care (arm C)
- Where
- 2 sites in South Africa, Zambia
- Volunteers
- 4,200 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Tuberculosis, Tuberculosis, Pulmonary
A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371
The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of TBA-7371 in healthy subjects
- Trial name
- NCT03199339
- Testing
- TBA-7371
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
PPD Size and Mycobacteria Tuberculosis ELISPOT in Children Who Have Received BCG in Neonate Period
To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o . Calculate the normal range of age specific PPD size in children who recieved BCG at new-born period.
- Trial name
- NCT00172783
- Where
- Taiwan
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Tuberculosis
Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI
Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. We are investigating a new skin test named C-Tb.
- Trial name
- NCT01631266
- Testing
- C-Tb, 2 T.U. Tuberculin PPD RT 23 SSI
- Where
- 13 sites in Spain
- Volunteers
- 979 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Tuberculosis
Study of AERAS-402 in Healthy Infants
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
- Trial name
- NCT01198366
- Testing
- AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp
- Where
- 7 sites in Kenya, Mozambique and 1 more
- Volunteers
- 487 people, healthy volunteers welcome
- Sponsor
- Aeras
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV
Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract infection in children under one year of age.
- Trial name
- EVA-VRS01 (NCT03213405)
- Testing
- rBCG-N-hRSV 1/100, rBCG-N-hRSV 1/10, rBCG-N-hRSV full dose
- Where
- Chile
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pontificia Universidad Catolica de Chile
Tuberculosis
A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi
Despite tremendous efforts, an effective tuberculosis (TB) vaccine remains elusive. TB continues to infect and kill many. In 2021, TB infected more than 10 million and killed 1.6 million people.
- Trial name
- MLWBCGCHIM (NCT06178666)
- Testing
- BCG
- Where
- Malawi
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Tuberculosis
Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy
This is a cohort observational study investigating the rate of tuberculosis (TB) recurrence in adult patients who have completed TB therapy for Pulmonary TB (PTB) and are on highly active antiretroviral therapy (HAART).The…
- Trial name
- TRuTH (NCT01539005)
- Where
- South Africa
- Volunteers
- 402 people, healthy volunteers welcome
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Cystic Fibrosis, Bronchiectasis Adult
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.
- Conditions
- Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria
- Trial name
- NCT04884308
- Testing
- BCG TICE Vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Lung Cancer, Small Cell Lung Cancer
A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose lung cancer by comparing with clinical standard method…
- Conditions
- Lung Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma
- Trial name
- NCT05337163
- Testing
- Diagnostic Test: Sputum DNA methylation analysis, chest CT or pathological examination
- Where
- China
- Volunteers
- 1,564 people, healthy volunteers welcome
- Sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.
Leprosy
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
This is a cluster randomized trial on effectiveness of different modalities of Single Double Dose of Rifampicin Post-Exposure Prophylaxis (SDDR-PEP) for leprosy in the Comoros (Anjouan and Mohéli) and Madagascar.
- Trial name
- PEOPLE (NCT03662022)
- Testing
- Rifampicin
- Where
- 3 sites in Comoros, Madagascar
- Volunteers
- 144,000 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Tuberculosis
A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
The recommended treatment for latent tuberculosis infection for adults is a daily dose of isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables.
- Trial name
- NCT02043314
- Testing
- Isoniazida
- Where
- Brazil
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
Tuberculosis
Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers
This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis.
- Trial name
- NCT01585636
- Testing
- SQ109
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Sequella, Inc.
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
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis (TB), Tuberculosis Infection, Latent
Screening With Portable X-rays for Rapid Recognition of TB
SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a community-based tuberculosis (TB) screening strategy for migrant populations in New York City.
- Conditions
- Tuberculosis (TB), Tuberculosis Infection, Latent, HIV (Human Immunodeficiency Virus)
- Trial name
- SPOT-TB (NCT07737275)
- Testing
- Mobile chest radiography for tuberculosis screening
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Columbia University
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
Healthy Adult Participants
A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose trial of TBD11 in healthy adults. It includes a dedicated open-label cohort in which TBD11 will be administered as a single dose with either a strong…
- Trial name
- NCT07883226
- Testing
- TBD11 (300 mg), Itraconazole (200 mg), Rifampicin 600mg
- Where
- South Africa
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
HIV Infections, Tuberculosis
Characteristics and Prevalence of Tuberculosis and HIV in Masiphumelele Township, Cape Town, South Africa
The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV.
- Trial name
- NCT00346476
- Where
- 2 sites in South Africa
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
Tuberculosis
Phase 1 Study of PBTZ169
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
- Trial name
- NCT03036163
- Testing
- PBTZ169 - 40 mg, PBTZ169 - 80 mg, PBTZ169 - 160 mg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC