Clinical trials: Mycobacterium Tuberculosis Infection
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
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.
- Trial name
- NCT00707967
- Testing
- GSK's candidate Mycobacterium tuberculosis vaccine 692342, Control vaccine with the adjuvant system., Control vaccine with physiological saline
- Where
- Switzerland
- Volunteers
- 37 people
- Sponsor
- GlaxoSmithKline
Tuberculosis
TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection
Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifapentine/isoniazid for three…
- Trial name
- NCT00164450
- Testing
- Isoniazid, Rifapentine
- Where
- 24 sites in United States, Brazil and 2 more
- Volunteers
- 158 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis
Pretomanid in Adults With Hepatic Impairment
This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects.
- Trial name
- NCT02422524
- Testing
- PA-824
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, AIDS-related Complex
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
- Trial name
- NCT00201123
- Testing
- Aerosol Interferon-Gamma, Subcutaneous interferon-gamma
- Where
- 2 sites in United States, South Africa
- Volunteers
- 89 people
- Sponsor
- NYU Langone Health
Latent Tuberculosis Infection
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial.
- Trial name
- iAdhere (NCT01582711)
- Testing
- Self Administered Therapy (SAT), SMS reminders, isoniazid and rifapentine
- Where
- 12 sites in United States, China and 2 more
- Volunteers
- 1,002 people
- Sponsor
- Centers for Disease Control and Prevention
Multidrug-resistant Tuberculosis, Extensively Drug-resistant Tuberculosis
Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients
Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA) in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) due to possible synergistic activity as…
- Trial name
- NCT01521364
- Testing
- Addition of different doses of clarithromycin.
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- University Medical Center Groningen
MDR-TB, HIV
A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs.
- Trial name
- NCT02129244
- Testing
- NCM-Plus
- Where
- 15 sites in South Africa
- Volunteers
- 2,844 people
- Sponsor
- Johns Hopkins University
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- NCT03338621
- Testing
- Pretomanid, Bedaquiline, Moxifloxacin
- Where
- 26 sites in Brazil, Georgia and 6 more
- Volunteers
- 455 people
- Sponsor
- Global Alliance for TB Drug Development
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)
Covid19, Tuberculosis
New Reusable Mask Design With Superior Filtration and Fit
This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic.
- Conditions
- Covid19, Tuberculosis, Respiratory Viral Infection
- Trial name
- NCT04826809
- Testing
- N95 mask, Nordell single E-100 layer mask, Nordell double E-100 layer mask
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Tuberculosis
Trial of High-Dose Rifampin in Patients With TB
The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to shorten treatment for tuberculosis (TB) without causing more adverse events.
- Trial name
- HIRIF (NCT01408914)
- Testing
- Higher-Dose Rifampin
- Where
- 4 sites in United States, Peru and 1 more
- Volunteers
- 180 people
- Sponsor
- Harvard University Faculty of Medicine
HIV, Tuberculosis
Sustainable East Africa Research in Community Health
The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach.
- Conditions
- HIV, Tuberculosis, Hypertension, Diabetes
- Trial name
- SEARCH (NCT01864603)
- Testing
- Universal ART in a streamlined care model, Annual Community Health Campaigns, Targeted PrEP and Targeted testing interventions
- Where
- 3 sites in Kenya, Uganda
- Volunteers
- 150,395 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
Pulmonary Tuberculosis
Assessing PA-824 for Tuberculosis (the APT Trial)
Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment.
- Trial name
- NCT02256696
- Testing
- PA-824, Rifampin, Rifabutin
- Where
- South Africa
- Volunteers
- 157 people
- Sponsor
- Johns Hopkins University
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
Pulmonary Disease, Tuberculosis, Pulmonary
A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT05526911
- Testing
- TBAJ-876, Midazolam, Digoxin
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342
The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule.
- Trial name
- NCT01669096
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents
Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents
- Trial name
- NCT02075203
- Testing
- AERAS-404, Bacillus Calmette-Guérin (BCG)
- Where
- 2 sites in South Africa
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Aeras
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)