Clinical trials: Active Tuberculosis
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Trial of Point-of-treatment Xpert MTB/RIF Assay
Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can detect TB genetic material in sputum samples as well as test for genetic resistance to rifampicin providing results within 2 hours.
- Trial name
- TBNEATXpert (NCT01554384)
- Testing
- Xpert MTB/RIF assay, Smear microscopy
- Where
- 4 sites in South Africa, Zambia and 1 more
- Volunteers
- 1,472 people
- Sponsor
- University of Cape Town
Tuberculosis, Non-Tuberculous Mycobacterial Pneumonia
Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium
The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in acid-fast bacilli smears, which are emerging in many…
- Trial name
- NCT03794284
- Testing
- VereMTB
- Where
- Hong Kong
- Volunteers
- 46 people
- Sponsor
- Chinese University of Hong Kong
Pulmonary Tuberculosis
AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT
Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of…
- Trial name
- AIPH-TB-RCT-P2 (NCT07467252)
- Testing
- Pyrazinamide and Hydroxychloroquine (AI-Optimised), Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)
- Where
- Saudi Arabia
- Volunteers
- 200 people
- Sponsor
- Ministry of Health, Saudi Arabia
Human Immunodeficiency Virus (HIV) Infection
Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis
SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS)…
- Trial name
- SaDAPT (NCT05452616)
- Testing
- ART first- Therapeutic use trial, TB results first- Therapeutic use trial
- Where
- 2 sites in Lesotho, Malawi
- Volunteers
- 610 people
- Sponsor
- University Hospital, Basel, Switzerland
Pulmonary TB
Promoting Overall Care and Management Related to Tuberculosis Infection Through Pharmaceutical Care and Text Messaging
This project aims to standardize the management of "Pharmaceutical care with the two-way text messages and incentive for mobile usage during the treatment for tuberculosis patients, to improve the outcomes and compliance, reduce…
- Trial name
- NCT04264221
- Testing
- New management mode
- Where
- 2 sites in Pakistan
- Volunteers
- 600 people
- Sponsor
- Farman Ullah Khan
Tuberculosis
Aerosol BCG Challenge Study in Historically BCG-vaccinated Volunteers
The purpose of this study is to evaluate the human clinical response to BCG challenge in historically BCG-vaccinated healthy adult volunteers. It will involve 12 participants in a controlled dose escalation.
- Trial name
- NCT04777721
- Testing
- BCG Danish
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Isoniazid Prophylaxis With Concomitant Cotrimoxazole in HIV-infected Children
The study involves use of isoniazid and cotrimoxazole as strategies for preventing infections in HIV-infected children and reducing mortality.
- Trial name
- NCT00330304
- Testing
- Isoniazid, Cotrimoxazole
- Where
- 2 sites in South Africa
- Volunteers
- 450 people
- Sponsor
- University of Cape Town
HIV/AIDS
Swaziland HIV Incidence Measurement Survey 2
The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators.
- Trial name
- SHIMS2 (NCT04117984)
- Where
- Eswatini
- Volunteers
- 15,429 people, healthy volunteers welcome
- Sponsor
- Columbia University
Pulmonary Tuberculosis
TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis
Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens.
- Trial name
- NCT00023335
- Testing
- Rifapentine, Isoniazid
- Where
- 23 sites in United States, Canada
- Volunteers
- 1,000 people
- Sponsor
- Centers for Disease Control and Prevention
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
HIV Infection, Tuberculosis Infection
Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients
The role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control.
- Trial name
- miRNA (NCT03941210)
- Testing
- Detection of molecular Biomarkers
- Where
- Cambodia
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Tuberculosis, Multidrug-Resistant
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of…
- Trial name
- PROSPECT (NCT05306223)
- Testing
- Bedaquiline, Levofloxacin, Linezolid
- Where
- 17 sites in China
- Volunteers
- 212 people
- Sponsor
- Beijing Chest Hospital
Tuberculosis
The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa
The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able…
- Trial name
- XACT (NCT01990274)
- Testing
- GeneXpert MTB/RIF assay, Smear microscopy
- Where
- 4 sites in Italy, Netherlands and 2 more
- Volunteers
- 875 people
- Sponsor
- University of Cape Town
Tuberculosis
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.
- Trial name
- NCT02066428
- Testing
- AERAS-404
- Where
- Sweden
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Phase 2a Study of PBTZ169
Multicenter, open, randomized study with active control (isoniazid) to evaluate the early antibacterial activity, safety and pharmacokinetics of the drug PBTZ169 (capsules 80 mg) when used in patients with first-diagnosed…
- Trial name
- NCT03334734
- Testing
- PBTZ169, Isoniazid
- Volunteers
- 16 people
- Sponsor
- Nearmedic Plus LLC
Pulmonary Tuberculosis (TB)
Safety, Tolerability, Extended Early Bactericidal Activity and PK of Higher Doses Rifampicin in Adults With Pulmonary TB
This is the first trial in a series of clinical trials that aim to bring the concept of high dose rifampicin beyond phase II of clinical development.
- Trial name
- HR1 (NCT01392911)
- Testing
- Rifampicin
- Where
- 2 sites in South Africa
- Volunteers
- 128 people
- Sponsor
- Radboud University Medical Center
Lung Diseases, Tuberculosis
Tuberculosis Prophylaxis in the Homeless--A Controlled Trial
To conduct a three-arm, randomized controlled trial of methods to improve adherence to biweekly directly observed prophylaxis (DOPT) for tuberculosis in homeless adults in San Francisco.
- Trial name
- NCT00005737
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Tuberculosis in HIV-infected Individuals, Drug Susceptible Pulmonary Tuberculosis
Short-Course Regimens for DS-PTB in AIDS Patients
This study adopts a multicenter, open-label, randomized controlled design, conducted across key designated AIDS diagnosis and treatment hospitals nationwide.
- Trial name
- NCT07608172
- Testing
- 2HPMZ/2HPM, 2HRZE/4HR
- Volunteers
- 148 people
- Sponsor
- Shanghai Public Health Clinical Center
Tuberculosis, TB Infection
A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia
- Trial name
- NCT07647107
- Testing
- LipovaxinS4-EAH (Middle Dose), LipovaksinS4-EAH (High Dose)
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma