Clinical trials: Drug Sensitive Tuberculosis
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
PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay
PNU-100480 is being developed for the treatment of both drug resistant and sensitive tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480 when given for 14 days to treatment-naive patients…
- Trial name
- NCT01225640
- Testing
- PNU-100480, RHZE
- Where
- 2 sites in South Africa
- Volunteers
- 59 people
- Sponsor
- Sequella, Inc.
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
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
Tuberculosis, Pulmonary
Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to treat with multiple drugs for 6 months, although patients often fail to adhere to the long treatment, leading to poor clinical outcomes…
- Trial name
- TRUNCATE-TB (NCT03474198)
- Testing
- Rifampicin, Isoniazid, Pyrazinamide
- Where
- 18 sites in India, Indonesia and 4 more
- Volunteers
- 675 people
- Sponsor
- University College, London
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
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
Tuberculosis
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
- Trial name
- NC-005 (NCT02193776)
- Testing
- PA-824, bedaquiline, moxifloxacin
- Where
- 10 sites in South Africa, Tanzania and 1 more
- Volunteers
- 240 people
- Sponsor
- Global Alliance for TB Drug Development
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
A Trial of the C-Tb Skin Test, When Given Intradermally to Adult Patients Recently Diagnosed With Active Tuberculosis (TB)
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. The new skin test is named C-Tb.
- Trial name
- TESEC-04 (NCT01241188)
- Testing
- C-Tb, 2 TU Tuberculin PPD RT 23 SSI
- Where
- South Africa
- Volunteers
- 253 people
- Sponsor
- Statens Serum Institut
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
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
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
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, Pulmonary
Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)
Tuberculosis (TB) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens.
- Trial name
- ORIENT (NCT05401071)
- Testing
- Short Regimen with Rifapentine 10mg/kg, Standardized Regimen, Short Regimen with Rifapentine 15mg/kg
- Where
- 6 sites in China
- Volunteers
- 2,442 people
- Sponsor
- Huashan Hospital
Respiratory Disease, Substance-Related Disorders
Development of the Drug and Alcohol Respiratory Health Test
The goal of this study is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and offer it for routine use in clinical assessment and medical reviews
- Conditions
- Respiratory Disease, Substance-Related Disorders, COPD, Asthma
- Trial name
- DARHT (NCT06921278)
- Where
- United Kingdom
- Volunteers
- 260 people
- Sponsor
- King's College London
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
Tuberculosis
TB Host Directed Therapy
To examine the safety and preliminary efficacy of multiple adjunctive host directed TB therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent permanent lung damage.
- Trial name
- TBHDT (NCT02968927)
- Testing
- Everolimus 0.5 MG, Auranofin 6 MG, Vitamin D3
- Where
- South Africa
- Volunteers
- 200 people
- Sponsor
- The Aurum Institute NPC