Clinical trials: Pulmonary Tuberculosis (TB)
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
Pretomanid is being used in an antimicrobial combination regimen(s) to treat patients with pulmonary tuberculosis (TB). The primary purpose of the Male Reproductive Safety - "BPaMZ/SEM"- clinical study is to evaluate the…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- PaSEM (NCT04179500)
- Testing
- Pretomanid, Bedaquiline, moxifloxacin
- Where
- 4 sites in Georgia, South Africa
- Volunteers
- 26 people
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Pulmonary Tuberculosis
A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture…
- Trial name
- NCT02333799
- Testing
- Bedaquiline, PA-824, Linezolid
- Where
- 3 sites in South Africa
- Volunteers
- 109 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
Tuberculosis
Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
The purpose of this study is: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background…
- Trial name
- NCT01131351
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 3 sites in Latvia, Lithuania
- Volunteers
- 10 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Pulmonary Tuberculosis
Using Biomarkers to Predict TB Treatment Duration
Background: Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts about 6 months. Some people with less severe TB might not need to take the drugs that long.
- Trial name
- NCT02821832
- Testing
- Saliva collection, Urine collection, Sputum collection
- Where
- South Africa
- Volunteers
- 946 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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.
Tuberculosis
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, Multidrug-Resistant, Tuberculosis
Linezolid Dosing Strategies in Drug-Resistant TB
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- NCT05007821
- Testing
- Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW)
- Where
- 13 sites in Botswana, Brazil and 5 more
- Volunteers
- 138 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Tuberculosis Treatment Shortening Trial
Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then take 2 of the same medicines for 4 more…
- Trial name
- NCT00130247
- Testing
- Ethambutol, Isoniazid, Pyrazinamide
- Where
- 3 sites in Brazil, Philippines and 1 more
- Volunteers
- 394 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 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.
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
HIV/AIDS, Tuberculosis, Pulmonary
INSTI's For The Management of HIV-associated TB
This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected…
- Trial name
- INSIGHT (NCT04734652)
- Testing
- Biktarvy®, TLD- fixed-drug combination single tablet
- Where
- South Africa
- Volunteers
- 122 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Tuberculosis, Pulmonary
A Clinical Risk Score for Early Management of TB in Uganda
Although curative treatment exists, tuberculosis (TB) remains the leading cause of infectious mortality worldwide - often because people seek care for TB symptoms in highly resource-constrained clinics that cannot provide…
- Trial name
- PredicTB (NCT05122624)
- Testing
- PredicTB score
- Where
- Uganda
- Volunteers
- 3,332 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Tuberculosis, Pulmonary
Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design
This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized, controlled clinical trial that will compare the efficacy and safety of four experimental four drug regimens with a standard control regimen in…
- Trial name
- NCT01785186
- Testing
- SQ109, Rifampicin, Moxifloxacin
- Where
- 7 sites in South Africa, Tanzania
- Volunteers
- 365 people
- Sponsor
- Michael Hoelscher
Tuberculosis
A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB
This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity study in adults who have recently been successfully treated for drug-susceptible pulmonary Tuberculosis (TB).
- Trial name
- C-037-456 (NCT02375698)
- Testing
- H56:IC31
- Where
- 3 sites in South Africa
- Volunteers
- 22 people
- Sponsor
- Aeras
Pulmonary Tuberculosis
TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment
This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment.
- Trial name
- NCT00694629
- Testing
- rifapentine, rifapentine 10 mg/kg, rifapentine 15 mg/kg
- Where
- 29 sites in United States, Brazil and 4 more
- Volunteers
- 334 people
- Sponsor
- Centers for Disease Control and Prevention