Clinical trials: Tuberculosis, Pulmonary, Drug Sensitive
Pulmonary TB, Pulmonary Tuberculosis
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult…
- Conditions
- Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
- Trial name
- NCT06058299
- Testing
- sorfequiline, Pretomanid, Linezolid
- Where
- 22 sites in Georgia, Philippines and 3 more
- Volunteers
- 309 people
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary Tuberculosis
A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)
The purpose of this study is to evaluate the mycobactericidal activity, safety, tolerability, and pharmacokinetics of 6 doses of linezolid: 300 mg once per day, 300 mg twice per day, 600 mg once per day, 600 mg twice per day and…
- Trial name
- NCT02279875
- Testing
- Linezolid, HRZE (isoniazid rifampicin,pyrazinamide,ethambutol)
- Where
- 2 sites in South Africa
- Volunteers
- 113 people
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary Tuberculosis
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid…
- Trial name
- NCT05971602
- Testing
- Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)
- Where
- 13 sites in Philippines, South Africa
- Volunteers
- 93 people
- Sponsor
- Gates Medical Research Institute
Pulmonary Tuberculosis, Other Specified Pulmonary Tuberculosis
PanACEA Sutezolid Dose-finding and Combination Evaluation
This study is an open-label, randomized, controlled, multi-center Phase IIB dose-finding trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response-relationship of different doses of sutezolid (STZ) in…
- Trial name
- SUDOCU (NCT03959566)
- Testing
- Sutezolid, Bedaquiline, Delamanid, Moxifloxacin, Midazolam oral solution
- Where
- 4 sites in South Africa, Tanzania
- Volunteers
- 75 people
- Sponsor
- Michael Hoelscher
Tuberculosis, Pulmonary, Tuberculosis, MDR
Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
The purpose of this study is to assess the efficacy and safety of 2 repurposed drugs (acetylsalicylic acid and ibuprofen), for use as adjunct therapy added to, and compared with, the standard of care (SoC) WHO-recommended TB…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, MDR, Tuberculosis Infection
- Trial name
- SMA-TB (NCT04575519)
- Testing
- Control group, ASA group, IBU group
- Where
- 3 sites in Georgia, South Africa
- Volunteers
- 426 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
Tuberculosis, Pulmonary
Study of Combinations of Novel Promising Drugs for Pulmonary Tuberculosis
A phase 2, two-part, multicentre, open label, controlled, randomised clinical trial in adult participants with newly diagnosed, sputum-positive pulmonary drug-sensitive tuberculosis (DSTB).
- Trial name
- SYNERGY (NCT07773610)
- Testing
- TBAJ-587 50 mg, Pretomanid 200mg, Linezolid 600Mg Tab
- Where
- South Africa
- Volunteers
- 135 people
- Sponsor
- TASK Applied Science
Pulmonary Tuberculosis
Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.
- Trial name
- NCT01498419
- Testing
- Moxifloxacin (M), Pretomid (Pa), Pyrazinamide (Z)
- Where
- 8 sites in South Africa, Tanzania
- Volunteers
- 207 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Tuberculosis Infection, Latent
Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan
RIFA-REAL is a prospective observational longitudinal study evaluating the safety, feasibility, and effectiveness of rifapentine-based shorter treatment regimens for drug-susceptible tuberculosis (DS-TB) and tuberculosis…
- Conditions
- Tuberculosis, Tuberculosis Infection, Latent, Tuberculosis, Pulmonary, Drug Sensitive
- Trial name
- RIFA-REAL (NCT07668479)
- Volunteers
- 350 people
- Sponsor
- Public Union "Kazakhstan Association of Phthisiopulmonologists"
Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
- Trial name
- NCT03563599
- Testing
- Telacebec (Q203), Rifafour e-275
- Where
- 2 sites in South Africa
- Volunteers
- 60 people
- Sponsor
- Qurient Co., Ltd.
TB - Tuberculosis, TB
Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity.
- Conditions
- TB - Tuberculosis, TB, TB Infection
- Trial name
- TB Pure (NCT07164742)
- Testing
- 8 week (short arm) Intervention - pulmonary rehabilitation, 24 week (long arm) Intervention - pulmonary rehabilitation
- Where
- 2 sites in India
- Volunteers
- 690 people
- Sponsor
- Johns Hopkins University
Pulmonary Tuberculosis, Other Specified Pulmonary Tuberculosis
PanACEA - STEP2C -01
This is a phase 2B/C, open label platform study that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis.
- Trial name
- NCT05807399
- Testing
- BTZ-043, Rifampicin, Isoniazid
- Where
- 10 sites in Gabon, Malawi and 4 more
- Volunteers
- 390 people
- Sponsor
- Michael Hoelscher
Tuberculosis, Pulmonary
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
The purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after Culture Conversion) for the treatment of drug-sensitive pulmonary…
- Trial name
- Hi-DoRi-3 (NCT04485156)
- Testing
- High-dose rifampicin, Isoniazid, Pyrazinamide
- Where
- South Korea
- Volunteers
- 926 people
- Sponsor
- Seoul National University Hospital
Pulmonary Tuberculosis
AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT
Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of…
- Trial name
- AIPH-TB-RCT-P2 (NCT07467252)
- Testing
- Pyrazinamide and Hydroxychloroquine (AI-Optimised), Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)
- Where
- Saudi Arabia
- Volunteers
- 200 people
- Sponsor
- Ministry of Health, Saudi Arabia
Pulmonary Tuberculosis
Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers
This trial aims to determine whether the early bactericidal activity of rifampicin given with faropenem or cefadroxil (each given with amoxicillin/clavulanic acid) is greater than the activity of rifampicin alone in patients with…
- Trial name
- NCT02381470
- Testing
- Faropenem, Amoxicillin/clavulanic acid, Cefadroxil
- Where
- 6 sites in Philippines, Singapore and 1 more
- Volunteers
- 58 people
- Sponsor
- National University Hospital, Singapore
Pulmonary Disease, Tuberculosis, Pulmonary
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to…
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04493671
- Testing
- TBAJ-876 suspension, TBAJ-876 100 mg tablet, TBAJ-876 25 mg tablet
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Drug Susceptible Pulmonary Tuberculosis
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.
- Trial name
- NCT07525427
- Testing
- Bedaquiline, pretomanid and TBD09, Bedaquiline, pretomanid and linezolid
- Where
- 13 sites in South Africa
- Volunteers
- 150 people
- Sponsor
- Gates Medical Research Institute
Tuberculosis, Pulmonary
Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200/100SPaL-4/13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive…
- Trial name
- NCT07672405
- Testing
- sorfequiline, Pretomanid, Linezolid
- Where
- 12 sites in South Africa, Tanzania
- Volunteers
- 100 people
- Sponsor
- Global Alliance for TB Drug Development
Chronic Respiratory Conditions
Pulmonary Rehabilitation in African Countries
Chronic Respiratory Diseases (CRDs) are common disabling conditions worldwide with high prevalence, morbidity and mortality. More than half of the CRD patients live in low- and middle-income countries (LMICs) where resources for…
- Trial name
- NCT07602673
- Testing
- Centre-based Pulmonary Rehabilitation, Community-based Pulmonary Rehabilitation
- Where
- 3 sites in Cameroon, Nigeria and 1 more
- Volunteers
- 150 people
- Sponsor
- University of Edinburgh
Tuberculosis, Pulmonary, Other Specified Pulmonary Tuberculosis
BTZ-043 Dose Evaluation in Combination and Selection
This is a phase 2B, open label study, that will compare the safety and efficacy of three experimental regimens consisting of bedaquiline and delamanid in combination with different doses of BTZ-043, a novel antibiotic, in adult…
- Trial name
- DECISION (NCT05926466)
- Testing
- BTZ-043, Bedaquiline, Delamanid
- Where
- 4 sites in South Africa, Tanzania
- Volunteers
- 92 people
- Sponsor
- Michael Hoelscher
Infections and Infestations, Pulmonary Tuberculosis
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose…
- Trial name
- DECODE (NCT04550832)
- Testing
- Delpazolid, Bedaquiline, Delamanid, Moxifloxacin
- Where
- 5 sites in South Africa, Tanzania
- Volunteers
- 76 people
- Sponsor
- LigaChem Biosciences, Inc.