Clinical trials: Mycobacterium Infections
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
Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis
BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
This is a prospective, open label, two-centre, randomized, controlled, two-stage, phase Ib/IIa study to evaluate the safety, tolerability, PK, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once…
- Trial name
- NCT04044001
- Testing
- BTZ-043, Rifafour e-275®, Probe Drug Cocktail
- Where
- 2 sites in South Africa
- Volunteers
- 78 people
- Sponsor
- Michael Hoelscher
Latent Tuberculosis
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care
This study explores primary care team members' knowledge, attitudinal, and skill gaps related to latent tuberculosis infection (LTBI) testing and treatment.
- Trial name
- NCT04188041
- Testing
- TB Infection ECHO
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Kent Hospital, Rhode Island
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Tuberculosis
A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential.
- Trial name
- C-010-402 (NCT02414828)
- Testing
- AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp, AERAS-402 3 x 10^10 vp
- Where
- South Africa
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aeras
Pulmonary Tuberculosis, Multidrug Resistant Tuberculosis
Linezolid to Treat Extensively-Drug Resistant Tuberculosis
This study, conducted in Masan and Seoul, South Korea, investigated the effectiveness of linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB).
- Conditions
- Pulmonary Tuberculosis, Multidrug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
- Trial name
- NCT00727844
- Testing
- Immediate Start Linezolid, Delayed Start Linezolid
- Where
- 2 sites in South Korea
- Volunteers
- 41 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)
Pulmonary Tuberculosis, Body Weight Changes
Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting. Wasting reduces lean body mass and may cause physical function impairment.
- Conditions
- Pulmonary Tuberculosis, Body Weight Changes, Motor Activity
- Trial name
- FSS (NCT02554318)
- Testing
- Rifampicin, Isoniazid, Pyrazinamide
- Volunteers
- 147 people
- Sponsor
- University of Giessen
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
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.
Tuberculosis
TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB).
- Trial name
- S31/A5349 (NCT02410772)
- Testing
- rifapentine, rifapentine and moxifloxacin, control
- Where
- 33 sites in United States, Brazil and 11 more
- Volunteers
- 2,516 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
- Trial name
- NCT02253537
- Testing
- CST001
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Tuberculosis
Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed.
- Trial name
- NCT00082173
- Testing
- Moxifloxacin
- Where
- Brazil
- Volunteers
- 170 people
- Sponsor
- Johns Hopkins University
Tuberculosis, Alcohol Consumption
The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes
After HIV/AIDS, tuberculosis (TB) remains the second leading cause of death due to an infectious disease globally. Retrospective studies from many countries, including the United States and South Africa, have consistently…
- Conditions
- Tuberculosis, Alcohol Consumption, Treatment Adverse Effect
- Trial name
- NCT02840877
- Testing
- DOT Adherence Monitoring
- Where
- South Africa
- Volunteers
- 303 people
- Sponsor
- Boston Medical Center
Tuberculosis, Pulmonary, Antibiotic Prophylaxis
Prevention of Tuberculosis in Prisons
The purpose of this study is to determine if the isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity of the disease.
- Trial name
- NCT03028129
- Testing
- Isoniazid 900 milligrams
- Where
- Brazil
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- Federal University of Mato Grosso
HIV/AIDS, Tuberculosis
Prevent TB: Choice Architecture for TPT Delivery
Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what the investigators know works and what is actually delivered at the clinic-level…
- Trial name
- NCT04466488
- Testing
- Choice Architecture
- Where
- South Africa
- Volunteers
- 50,798 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
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
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
Melanoma
A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.
- Trial name
- NCT01308762
- Testing
- Heat killed whole cell M. obuense (IMM-101) 0.1 mg, Heat-killed whole cell M.obuense (IMM-101) 0.5 mg, Heat killed whole cell M.obuense (IMM-101) 1.0 mg
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Immodulon Therapeutics Ltd
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