Clinical trials: Mycobacterium Infection
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and…
- Trial name
- NCT01215851
- Testing
- PA-824, Pyrazinamide, TMC207
- Where
- 2 sites in South Africa
- Volunteers
- 85 people
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary TB
Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and…
- Trial name
- NCT03722472
- Testing
- ID93 + GLA-SE
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by…
- Conditions
- Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection
- Trial name
- NCT04922554
- Testing
- Omadacycline Oral Tablet
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- Paratek Pharmaceuticals Inc
Tuberculosis, HIV Infections
Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)
This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults.
- Trial name
- NCT01151189
- Testing
- MVA85A/AERAS-485
- Where
- 2 sites in Senegal, South Africa
- Volunteers
- 650 people
- Sponsor
- Aeras
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
Asthma, Sleep Apnea Syndromes
Service Development: Assessing Non-attendance Rates in Outpatient Clinics
Many studies have shown a high non-attendance rate in hospital outpatient clinics. The investigators have found a non-attendance rate of 25% in their asthma clinics and would like to investigate whether a reminder phone call will…
- Conditions
- Asthma, Sleep Apnea Syndromes, Tuberculosis, COPD
- Trial name
- NCT00129649
- Testing
- Telephone reminder call
- Where
- United Kingdom
- Volunteers
- 504 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Tuberculosis, Pulmonary, Rifampicin Resistant Tuberculosis
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing.
- Trial name
- XPEL-TB (NCT03044158)
- Testing
- GeneXpert I, Process re-design, Performance Feedback
- Where
- 20 sites in Uganda
- Volunteers
- 10,644 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Renal Cell Carcinoma (RCC)
Study of Safety and Functional Imaging of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma
This clinical trial explores the safety, efficacy, and effects on functional imaging of cG250 monoclonal antibody (mAb) administered intravenously weekly in combination with daily oral sunitinib, in patients with advanced renal…
- Trial name
- NCT00520533
- Testing
- Chimeric monoclonal antibody cG250, Sunitinib malate
- Where
- Australia
- Volunteers
- 8 people
- Sponsor
- Ludwig Institute for Cancer Research
MAC Lung Disease, Treatment Refractory MAC Lung Disease
Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
This is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease.
- Trial name
- NCT05327803
- Testing
- Epetraborole
- Where
- 91 sites in United States, Australia and 2 more
- Volunteers
- 177 people
- Sponsor
- AN2 Therapeutics, Inc
Mycobacterium Infections, Atypical
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
- Trial name
- NCT01097005
- Where
- 59 sites in Japan
- Volunteers
- 466 people
- Sponsor
- Mylan Inc.
Tuberculosis
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane®…
- Trial name
- NCT01311505
- Testing
- Myrin© 2 (Rifampicin + Isoniazid), Rimactane® (Rifampicin)
- Where
- Philippines
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tuberculosis
Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults
This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test.
- Trial name
- NCT00621322
- Testing
- GSK Biologicals' AS01B adjuvant, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2
- Where
- Philippines
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Infant TB Infection Prevention Study
Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.
- Trial name
- iTIPS (NCT02613169)
- Testing
- Isoniazid
- Where
- Kenya
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV/AIDS, Tuberculosis
Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)
There is an urgent global need to decrease the high mortality of tuberculosis (TB) in persons with HIV as TB is the leading cause of death among persons with HIV worldwide.
- Trial name
- DIPT (NCT03492216)
- Testing
- Incentives for negative EtG test, Incentives for positive IsoScreen test
- Where
- 2 sites in Uganda
- Volunteers
- 680 people
- Sponsor
- University of California, San Francisco
Tuberculosis, Tuberculosis, Pulmonary
Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda
In a previous randomized control trial, the investigators identified gaps in the implementation of tuberculosis (TB) contact investigation at multiple levels of the service delivery cascade.
- Trial name
- HCD-CoP (NCT05640648)
- Testing
- User-Centered Implementation Strategy, Standard Implementation Strategy
- Where
- Uganda
- Volunteers
- 10,477 people, healthy volunteers welcome
- Sponsor
- Yale University
HIV Infections, Tuberculosis
Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
The purpose of this pharmacokinetic (PK) study was to evaluate if a double dose (3 mg) of levonorgestrel (LNG) overcomes known drug-drug interactions (DDIs) with efavirenz (EFV)-based antiretroviral therapy (ART) or rifampicin…
- Trial name
- NCT03819114
- Testing
- Levonorgestrel (LNG)
- Where
- 18 sites in United States, Botswana and 5 more
- Volunteers
- 122 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV, Tuberculosis
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.
- Trial name
- NCT04518228
- Testing
- Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA)
- Where
- 23 sites in United States, Brazil and 6 more
- Volunteers
- 205 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
The Impact of Vitamin D on Tuberculosis Among Koreans
Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this study is to elucidate the role of vitamin D deficiency in development and treatment outcomes among Korean TB patients.
- Trial name
- NCT01137370
- Where
- South Korea
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
Human Immunodeficiency Virus
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV
The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).
- Trial name
- MESA-TB (NCT04556981)
- Testing
- M72/AS01E Mycobacterium tuberculosis vaccine
- Where
- 6 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Gates Medical Research Institute