Clinical trials: Active Tuberculosis
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 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
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
Tuberculosis, HIV I Infection
ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
This study will compare community-delivered, multi-month dispensing of tuberculosis preventive therapy (TPT) to standard-of-care clinic-based TPT delivery in a population of South African adults who are recommended to receive TB…
- Trial name
- ThiPhiSA (NCT06214910)
- Testing
- Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP), Clinic-link TPT
- Where
- South Africa
- Volunteers
- 301 people
- Sponsor
- University of Washington
Tuberculosis
Ultra Curto (Ultra Short) TB Prevention Therapy
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
- Trial name
- NCT04703075
- Testing
- Rifapentine 600 mg and INH 300 mg, Rifapentine 900 mg and INH 900 mg
- Where
- 2 sites in Brazil
- Volunteers
- 531 people
- Sponsor
- Johns Hopkins University
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 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
Aerosol BCG Challenge Study in Historically BCG-vaccinated Volunteers
The purpose of this study is to evaluate the human clinical response to BCG challenge in historically BCG-vaccinated healthy adult volunteers. It will involve 12 participants in a controlled dose escalation.
- Trial name
- NCT04777721
- Testing
- BCG Danish
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults
This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults.
- Trial name
- NCT00397943
- Testing
- GSK's candidate Mycobacterium tuberculosis vaccine 692342, Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system, Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline
- Where
- Belgium
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Study of AERAS-402 in Healthy Infants
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
- Trial name
- NCT01198366
- Testing
- AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp
- Where
- 7 sites in Kenya, Mozambique and 1 more
- Volunteers
- 487 people, healthy volunteers welcome
- Sponsor
- Aeras
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
Tuberculosis
Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis
The Tuberculosis Trials Consortium (TBTC) Study 31 is a phase 3 trial evaluating rifapentine-containing regimens for treatment-shortening of drug-susceptible pulmonary tuberculosis.
- Trial name
- S31PK/PD (NCT02563327)
- Testing
- Rifapentine, Moxifloxacin, Rifampin
- Where
- 3 sites in United States, Uganda and 1 more
- Volunteers
- 2,516 people
- Sponsor
- Centers for Disease Control and Prevention
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
Obesity, Tuberculosis
Effect of Weight and/or Obesity on Ethambutol Drug Concentrations
This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol.
- Trial name
- NCT01048697
- Testing
- Ethambutol
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Texas Tech University Health Sciences Center
Tuberculosis
Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study.
- Trial name
- NCT05824091
- Testing
- MK-7762 (TBD09)
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Tuberculosis
Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection
Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month…
- Trial name
- PREVENT TB (NCT00023452)
- Testing
- RPT + INH once weekly for 3 months given by DOT, Isoniazid (INH) daily for 9 months
- Where
- 26 sites in United States, Brazil and 2 more
- Volunteers
- 8,053 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis
MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection
TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently…
- Trial name
- NCT02532036
- Testing
- Aerosol inhaled MVA85A, Intramuscular MVA85A
- Where
- 5 sites in United Kingdom
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
Indacaterol EfectIveness In COPD Patients With Tuberculosis History
This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.
- Trial name
- INFINITY (NCT01778062)
- Testing
- Indacaterol, Control
- Where
- 13 sites in South Korea
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
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