Clinical trials: Multidrug Resistant Tuberculosis
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multidrug-resistant Tuberculosis
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.
- Trial name
- NCT01424670
- Testing
- Delamanid + OBR
- Where
- 17 sites in Estonia, Latvia and 5 more
- Volunteers
- 511 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Multi-drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).
- Trial name
- LiMiT (NCT00664313)
- Testing
- Linezolid
- Where
- South Africa
- Volunteers
- 36 people
- Sponsor
- Centers for Disease Control and Prevention
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
- Trial name
- NCT04150224
- Testing
- PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Tuberculosis, Multidrug-Resistant
Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB
Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around the world. This type of tuberculosis is very difficult to treat, and many patients die from it.
- Trial name
- Opti-Q (NCT01918397)
- Testing
- Levofloxacin, Optimized background regimen (OBR)
- Where
- 3 sites in Peru, South Africa
- Volunteers
- 111 people
- Sponsor
- Boston University
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
Tuberculosis
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB.
- Trial name
- NCT00449644
- Testing
- TMC207, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- Where
- 16 sites in Brazil, India and 6 more
- Volunteers
- 208 people
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, HIV Infections
Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis
This study evaluated the safety, tolerability, and pharmacokinetics of the anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in combination, among participants (with or without HIV co-infection) taking…
- Trial name
- NCT02583048
- Testing
- Bedaquiline, Delamanid, Dolutegravir
- Where
- 3 sites in Peru, South Africa
- Volunteers
- 84 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multi-Drug Resistant Tuberculosis
Metronidazole for Pulmonary Tuberculosis (South Korea)
This study will evaluate the effect of adding metronidazole to standard second-line therapy for tuberculosis in patients who have multi-drug resistant tuberculosis (MDR-TB) of the lungs.
- Trial name
- NCT00425113
- Testing
- Metronidazole, Blood Draw, CT Scan
- Where
- 2 sites in South Korea
- Volunteers
- 35 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, HIV
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed…
- Trial name
- NCT02906007
- Testing
- Bedaquiline
- Where
- 4 sites in Haiti, South Africa
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Multi-drug Resistant Tuberculosis
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
- Trial name
- NCT04309656
- Testing
- Pretomanid
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
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)