Clinical trials: Tuberculosis, Pulmonary, Drug Sensitive
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
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
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
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
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
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, Multidrug-Resistant
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
- Trial name
- NCT06674291
- Testing
- No intervention (observational study)
- Volunteers
- 222 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
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
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
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 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
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
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