Clinical trials: Tuberculosis Active
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and…
- Trial name
- NCT01215851
- Testing
- PA-824, Pyrazinamide, TMC207
- Where
- 2 sites in South Africa
- Volunteers
- 85 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Phase 2a Study of PBTZ169
Multicenter, open, randomized study with active control (isoniazid) to evaluate the early antibacterial activity, safety and pharmacokinetics of the drug PBTZ169 (capsules 80 mg) when used in patients with first-diagnosed…
- Trial name
- NCT03334734
- Testing
- PBTZ169, Isoniazid
- Volunteers
- 16 people
- Sponsor
- Nearmedic Plus LLC
Tuberculosis, HIV Infections
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety…
- Trial name
- NCT01404312
- Testing
- Rifapentine (RPT), Isoniazid (INH), Pyridoxine (Vitamin B6)
- Where
- 45 sites in United States, Botswana and 8 more
- Volunteers
- 3,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rifampicin Susceptible Pulmonary Tuberculosis
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
A Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin…
- Trial name
- NCT06041919
- Testing
- RESP301, HRZE
- Where
- South Africa
- Volunteers
- 20 people
- Sponsor
- Thirty Respiratory Limited
Tuberculosis, Pulmonary
Early Bactericidal Activity of Rifampin + Meropenem + Amoxicillin/Clavulanate in Adults With Pulmonary TB
The overall goal of this exploratory proof-of-concept study is to determine whether, in participants with pulmonary tuberculosis caused by M.
- Trial name
- NCT03174184
- Testing
- Rifampin, MEROPENEM 2 grams TID, MEROPENEM 1 gram TID
- Where
- South Africa
- Volunteers
- 112 people
- Sponsor
- Johns Hopkins University
Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis
BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
This is a prospective, open label, two-centre, randomized, controlled, two-stage, phase Ib/IIa study to evaluate the safety, tolerability, PK, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once…
- Trial name
- NCT04044001
- Testing
- BTZ-043, Rifafour e-275®, Probe Drug Cocktail
- Where
- 2 sites in South Africa
- Volunteers
- 78 people
- Sponsor
- Michael Hoelscher
MAC Lung Disease, Treatment Refractory MAC Lung Disease
Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
This is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease.
- Trial name
- NCT05327803
- Testing
- Epetraborole
- Where
- 91 sites in United States, Australia and 2 more
- Volunteers
- 177 people
- Sponsor
- AN2 Therapeutics, Inc
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus…
- Trial name
- NC-003 (NCT01691534)
- Testing
- TMC207 (J), PA-824 (PA), pyrazinamide (Z)
- Where
- 2 sites in South Africa
- Volunteers
- 105 people
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary Tuberculosis, Body Weight Changes
Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting. Wasting reduces lean body mass and may cause physical function impairment.
- Conditions
- Pulmonary Tuberculosis, Body Weight Changes, Motor Activity
- Trial name
- FSS (NCT02554318)
- Testing
- Rifampicin, Isoniazid, Pyrazinamide
- Volunteers
- 147 people
- Sponsor
- University of Giessen
Pulmonary Tuberculosis
Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis
The purpose of this study is to assess the safety, early bactericidal activity (EBA) and pharmacokinetics of TBA-7371 in adult participants with rifampicin-sensitive tuberculosis and select dose regimen(s) for future studies.
- Trial name
- NCT04176250
- Testing
- TBA-7371, HRZE
- Where
- 4 sites in South Africa
- Volunteers
- 93 people
- Sponsor
- Gates Medical Research Institute
Tuberculosis
Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin, and moxifloxacin.
- Trial name
- NCT00396084
- Testing
- Gatifloxacin, Isoniazid, Levofloxacin
- Where
- 2 sites in United States, Brazil
- Volunteers
- 70 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)
Isoniazid (INH) is a drug commonly used to treat tuberculosis (TB) worldwide. Sometimes, the bacteria that cause TB can become resistant to INH.
- Trial name
- NCT01936831
- Testing
- Isoniazid, Vitamin B6
- Where
- 2 sites in Haiti, South Africa
- Volunteers
- 282 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Tuberculosis
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or…
- Trial name
- NCT05382312
- Testing
- GSK3036656, Bedaquiline, Delamanid
- Where
- South Africa
- Volunteers
- 127 people
- Sponsor
- GlaxoSmithKline
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive…
- Trial name
- NCT00944021
- Testing
- PA-824, Rifafour e-275 mg
- Volunteers
- 69 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Adherence, Medication
Mobile Health Intervention for Active Tuberculosis
The purpose of this study is to evaluate and further refine a mobile support tool for patients receiving treatment for active tuberculosis.
- Trial name
- NCT03544476
- Testing
- Mobile phone TB treatment support app plus usual care, Usual care
- Where
- Argentina
- Volunteers
- 42 people
- Sponsor
- University of Washington
Pulmonary Tuberculosis
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive…
- Trial name
- NCT00567840
- Testing
- PA-824
- Where
- 2 sites in South Africa
- Volunteers
- 69 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Tuberculosis remains a concerning health problem, with Mycobacterium Tuberculosis (MTB) now causing more deaths than acquired immune deficiency syndrome (AIDS).
- Trial name
- NCT03557281
- Testing
- GSK3036656, Rifafour e-275
- Where
- South Africa
- Volunteers
- 76 people
- Sponsor
- GlaxoSmithKline
Tuberculosis
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB.
- Trial name
- NCT00449644
- Testing
- TMC207, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- Where
- 16 sites in Brazil, India and 6 more
- Volunteers
- 208 people
- Sponsor
- Janssen Infectious Diseases BVBA
HIV Infection, Tuberculosis
Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV
There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor (PI)-based antiretroviral therapy (ART).
- Trial name
- NCT01601626
- Testing
- Standard-dose Lopinavir/Ritonavir, Double-dose Lopinavir/Ritonavir, Raltegravir
- Where
- 9 sites in Brazil, Haiti and 3 more
- Volunteers
- 71 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Pulmonary TB
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).
- Trial name
- NCT03678688
- Testing
- 10 mg OPC-167832, 30 mg OPC-167832, 90 mg OPC-167832
- Where
- 3 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.