Clinical trials: Mycobacterium
Pulmonary Tuberculosis
Using Biomarkers to Predict TB Treatment Duration
Background: Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts about 6 months. Some people with less severe TB might not need to take the drugs that long.
- Trial name
- NCT02821832
- Testing
- Saliva collection, Urine collection, Sputum collection
- Where
- South Africa
- Volunteers
- 946 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Tuberculosis
Characteristics and Prevalence of Tuberculosis and HIV in Masiphumelele Township, Cape Town, South Africa
The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV.
- Trial name
- NCT00346476
- Where
- 2 sites in South Africa
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
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
Phase 1 Study of PBTZ169
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
- Trial name
- NCT03036163
- Testing
- PBTZ169 - 40 mg, PBTZ169 - 80 mg, PBTZ169 - 160 mg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Tuberculosis
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.
- Trial name
- NCT05203068
- Testing
- Recombinant tuberculosis allergen (RTA)
- Where
- Russia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases
HIV Infections, Tuberculosis
Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income settings and can be a serious complication for HIV-infected pregnant women and their infants.
- Trial name
- NCT01494038
- Testing
- Isoniazid (INH)
- Where
- 13 sites in Botswana, Haiti and 6 more
- Volunteers
- 956 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection
- Trial name
- DAR-PIA (NCT02712424)
- Testing
- DAR-901
- Where
- Tanzania
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center
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
Substance-Related Disorders, Mental Disorder
Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa
Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up…
- Conditions
- Substance-Related Disorders, Mental Disorder, Social Stigma, Depression
- Trial name
- Siyakhana (NCT05282173)
- Testing
- Siyakhana CHW Training
- Where
- South Africa
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of Maryland, College Park
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
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
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis
Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Choose healthy subjects and patients with TB, distribute them into different dose groups according to the recombinant EC allergen dose from low to high average.
- Trial name
- NCT02329730
- Testing
- 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Tuberculosis
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
- Trial name
- NCT02687529
- Testing
- CST001
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Tuberculosis
High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)
Isoniazid (INH) is a drug commonly used to treat tuberculosis (TB) worldwide. Sometimes, the bacteria that cause TB can become resistant to INH.
- Trial name
- NCT01936831
- Testing
- Isoniazid, Vitamin B6
- Where
- 2 sites in Haiti, South Africa
- Volunteers
- 282 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
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)
Tuberculosis
A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age
The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on…
- Trial name
- NCT06354257
- Testing
- Microgynon, GSK3036656
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin
The purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin.
- Trial name
- IMPACT-TB (NCT03891901)
- Testing
- Imatinib, Isoniazid, Rifabutin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
A Study of MVA85A in Healthy Infants
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection.
- Trial name
- NCT00953927
- Testing
- MVA85A/AERAS-485, Candida Skin Test Antigen
- Where
- 3 sites in South Africa
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Aeras