Clinical trials: Pulmonary Tuberculosis (TB)
TB, COVID-19
Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2)
This is a prospective, multicentre study in which the accuracy of the Molbio Diagnostics Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex will be assessed for TB and COVID-19 case detection using prospectively…
- Trial name
- Truenat COMBO (NCT05405296)
- Testing
- Truenat™ MTB Plus/COVID-19
- Where
- Uganda
- Volunteers
- 1,984 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
TB - Tuberculosis, PTLD
Intergrated Service Delivery for Lung Health Conditions
The Advancing Lung Health in Zambia project aims to improve access to integrated screening, diagnosis, and management of tuberculosis (TB) and other priority respiratory diseases at community and primary healthcare levels.
- Conditions
- TB - Tuberculosis, PTLD, COPD (Chronic Obstructive Pulmonary Disease), Computer Aided Diagnosis
- Trial name
- TB REACH W11 (NCT07816523)
- Testing
- Intergrated lung health screening, AI-Enabled Cough Sound Screening for Tuberculosis, Post-TB Lung Disease evaluation
- Where
- Zambia
- Volunteers
- 20,300 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Pulmonary Tuberculosis
Clinical Trial of Phenylbutyrate and Vitamin D in Tuberculosis (TB)
Vitamin D exerts its effects via the Vitamin D Receptor (VDR) present in activated macrophages and induces expression and release of the cathelicidin, LL-37, a human antimicrobial peptide involved in killing of MTB.
- Trial name
- NCT01580007
- Testing
- Active Sodium Phenylbutyrate and active cholecalciferol
- Where
- Bangladesh
- Volunteers
- 288 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
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, Pulmonary
Optimization of the TB Treatment Regimen Cascade
Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion using vital staining reduces unfavorable outcome of Cat.
- Trial name
- OneRIF (NCT02153528)
- Testing
- double rimfampicin, Standard TB treatment
- Where
- Bangladesh
- Volunteers
- 701 people
- Sponsor
- Damien Foundation
Tuberculosis, Human Immunodeficiency Virus
A Pragmatic Trial With Optimized Dose of Rifampicin and Moxifloxacin for the Treatment of Drug Susceptible Pulmonary Tuberculosis
Tuberculosis (TB) remains a major global public health problem, particularly in low- and middle-income countries (LMICs) in Africa, Asia, and Eastern Europe.
- Trial name
- OptiRiMoxTB (NCT05575518)
- Testing
- Optimised rifamycin
- Where
- Tanzania
- Volunteers
- 414 people
- Sponsor
- Stellah Mpagama
Tuberculosis
A Multiple Ascending Dose Study With a Dose Formulation Comparison Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
The objective of the study is to evaluate the safety and tolerability of multiple doses of TBA-354 in healthy subjects.
- Trial name
- NCT02606214
- Testing
- TBA-354
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Covid-19 Pandemics, Tuberculosis
Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
This study is a non-randomized observation and comparison of immune response between bacteriologically confirmed TB patients under treatment cohort who received COVID-19 vaccine (n=54) vs healthy individuals (n=54).
- Trial name
- CVTB (NCT05571735)
- Testing
- Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine, Janssen Ad26.COV2.S COVID-19 vaccine
- Where
- Thailand
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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)
Tuberculosis, Respiratory Tract Infections
Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)
This is a three-arm, open-label individually randomised controlled clinical trial investigating the benefits of the diagnostic use of broad-spectrum antimicrobials during the diagnostic process for tuberculosis (TB) and the risk…
- Conditions
- Tuberculosis, Respiratory Tract Infections, Pneumonia
- Trial name
- ACT-TB (NCT03545373)
- Testing
- Azithromycin, Amoxicillin
- Where
- Malawi
- Volunteers
- 1,583 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Tuberculosis, Pulmonary
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to…
- Trial name
- NCT04919239
- Testing
- RUTI®
- Where
- 2 sites in India
- Volunteers
- 140 people
- Sponsor
- Archivel Farma S.L.
Tuberculosis, Pulmonary
MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB. Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.
- Trial name
- NCT00495339
- Testing
- Levofloxacin
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Sanofi
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
PRACTECAL-PKPD Sub Study
PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial investigational regimens and…
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis
- Trial name
- PRACTECAL-PKPD (NCT04081077)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 5 sites in Belarus, South Africa
- Volunteers
- 240 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Pulmonary Tuberculosis, Other Specified Pulmonary Tuberculosis
PanACEA Sutezolid Dose-finding and Combination Evaluation
This study is an open-label, randomized, controlled, multi-center Phase IIB dose-finding trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response-relationship of different doses of sutezolid (STZ) in…
- Trial name
- SUDOCU (NCT03959566)
- Testing
- Sutezolid, Bedaquiline, Delamanid, Moxifloxacin, Midazolam oral solution
- Where
- 4 sites in South Africa, Tanzania
- Volunteers
- 75 people
- Sponsor
- Michael Hoelscher
Pulmonary Tuberculosis TB in Sputum: (+) Microscopy
Pilot Clinical Trial of PRS TB Regimen I - Phase II
Tuberculosis is the current leading cause of death due to an identifiable infectious agent worldwide. The current standard regimen for tuberculosis requires a patient to take drug combination (isoniazid, rifampicin, ethambutol…
- Trial name
- NCT03561753
- Testing
- Group A (the standard 2HRZE/4HR regimen）, Group B (New short course PRS regimen, 4EZ(high dose)PtoCfz)
- Where
- 4 sites in China
- Volunteers
- 97 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
TUBERCULOSIS, PULMONARY
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
- Trial name
- ISIT-TB (NCT04995406)
- Testing
- ISIT-TB prototype
- Where
- South Africa
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- BioMérieux
Infections and Infestations, Pulmonary Tuberculosis
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose…
- Trial name
- DECODE (NCT04550832)
- Testing
- Delpazolid, Bedaquiline, Delamanid, Moxifloxacin
- Where
- 5 sites in South Africa, Tanzania
- Volunteers
- 76 people
- Sponsor
- LigaChem Biosciences, Inc.
Tuberculosis
Early Risk Assessment in Household Contacts (≥10 Years) of TB Patients by New Diagnostic Tests in 3 African Countries
The ERASE - TB study will be conducted in order to fill a critical unmet need for tuberculosis control. Persons who are in contact with an infectious TB case may become infected themselves.
- Trial name
- ERASE-TB (NCT04781257)
- Testing
- New test candidates
- Where
- 3 sites in Mozambique, Tanzania and 1 more
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- Michael Hoelscher
Pulmonary Tuberculoses, Tuberculosis, Pulmonary
A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress
The objective of this study is to compare how accurately the Xpert MTB/RIF assay Ct value at diagnosis and the AI-based tuberculosis activity score predict the treatment outcome of rifampin-susceptible pulmonary tuberculosis…
- Trial name
- NCT05477966
- Testing
- Medical records review
- Where
- South Korea
- Volunteers
- 900 people
- Sponsor
- Jae-Joon Yim
Rifampicin- and Isoniazid-Susceptible Pulmonary Tuberculosis (TB)
A Phase 2 Trial to Evaluate the EBA, Safety and Tolerability of Eto Alone and in Combination With BVL-GSK098
To evaluate the 7-day early bactericidal activity (EBA), pharmacokinetics (PK), safety and tolerability of ethionamide (Eto) with or without BVL-GSK098 in participants with rifampicin- and isoniazid-susceptible pulmonary TB.
- Trial name
- BETO (NCT05473195)
- Testing
- BVL-GSK098 9mg, Ethionamide 250mg, Ethionamide 250 mg
- Where
- South Africa
- Volunteers
- 105 people
- Sponsor
- TASK Applied Science