Clinical trials: Pulmonary TB
Pulmonary Tuberculosis
Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis
The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated…
- Trial name
- NCT00401271
- Testing
- OPC-67683, Rifafour e-275
- Where
- 3 sites in South Africa
- Volunteers
- 54 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Tuberculosis, Tuberculosis, Pulmonary
Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
- Trial name
- NCT04865536
- Testing
- TBI-223 1800 mg, TBI-223 2400mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis
The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately…
- Trial name
- NCT06224608
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)
- Where
- 2 sites in China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Tuberculosis, Pulmonary
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
The goal of this observational study is to investigate whether model-informed precision dosing (MIPD), as a clinical support for early individualised dosing in addition to the national TB care program, can optimise the drug…
- Trial name
- DoseTB (NCT06585358)
- Testing
- MIPD
- Where
- 2 sites in Sweden
- Volunteers
- 30 people
- Sponsor
- Karolinska Institutet
Tuberculosis
Phenotyping of High Dose Rifampicin
Higher doses of rifampicin as a means of more efficient use of this pivotal TB drug has shown promising results and might become standard in future.
- Trial name
- PHENORIF (NCT04525235)
- Testing
- phenotyping cocktail, rifampicin
- Where
- 2 sites in South Africa
- Volunteers
- 25 people
- Sponsor
- Radboud University Medical Center
Post Tuberculosis
Mechanisms, Biomarkers and Pulmonary Rehabilitation in Post-TB Lung Disease
Tuberculosis (TB) affects millions of people worldwide, and many individuals continue to experience long-term health problems even after completing TB treatment.
- Trial name
- AFTER-TB (NCT07731009)
- Testing
- Pulmonary rehabilitation
- Volunteers
- 760 people
- Sponsor
- Jose Antonio Dominguez Benitez
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or…
- Trial name
- QUANTUM-TB (NCT07209761)
- Testing
- Bedaquiline, Quabodepistat, Pretomanid
- Where
- 42 sites in China, Georgia and 8 more
- Volunteers
- 532 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Respiratory Tract Infections, Tuberculosis, Pulmonary
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
This is an observational cohort study. Pulmonary tuberculosis (TB) patients will be enrolled at the time of TB diagnosis and prospectively followed for at least two years after TB-treatment initiation with optional prolonged…
- Trial name
- TBSEQUEL (NCT03251196)
- Testing
- No Intervention, and Observational Study
- Where
- 4 sites in Mozambique, South Africa and 2 more
- Volunteers
- 1,500 people
- Sponsor
- The Aurum Institute NPC
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)
Tuberculosis, AIDS-related Complex
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
- Trial name
- NCT00201123
- Testing
- Aerosol Interferon-Gamma, Subcutaneous interferon-gamma
- Where
- 2 sites in United States, South Africa
- Volunteers
- 89 people
- Sponsor
- NYU Langone Health
Tuberculosis, Pulmonary
VDOT and Mobile Payments in Cambodia
This project proposes to develop and pilot a novel smart phone-based intervention to improve tuberculosis (TB) treatment adherence in Cambodia, which integrates video-enabled Directly Observed Treatment (vDOT) with an automated…
- Trial name
- NCT03547479
- Testing
- VDOT, VDOT + mobile money
- Sponsor
- University of Southern California
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
Progressive Fibrosing Interstitial Lung Disease, Lung Transplant
Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From Wearable Devices in Respiratory Diseases
Lung diseases are one of the most common causes of emergency room visits. There are very few tools that are able to predict which patients will have a worsening or increasing severity of their condition.
- Conditions
- Progressive Fibrosing Interstitial Lung Disease, Lung Transplant, Cystic Fibrosis, Bronchiectasis
- Trial name
- NCT04857814
- Testing
- ADAMM- RSM Device
- Where
- Canada
- Volunteers
- 8 people
- Sponsor
- University of Alberta
Multi-drug Resistant Tuberculosis
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
- Trial name
- NCT03470233
- Where
- 2 sites in South Korea
- Volunteers
- 149 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Pulmonary Tuberculosis
Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB
Title: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB (Screen TB) Introduction: Tuberculosis (TB) places severe pressure on health care services of the developing world.
- Trial name
- ScreenTB (NCT03350048)
- Testing
- Trans-Dot point-of-care test
- Where
- 10 sites in Ethiopia, Germany and 6 more
- Volunteers
- 969 people
- Sponsor
- Prof Gerhard Walzl
Tuberculosis, Pulmonary
Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pulmonary TB
The development of efficacious, safe, and shorter treatment regimens could significantly improve TB management and treatment success rates.
- Trial name
- ESCAPE-TB (NCT04856644)
- Testing
- 4-month rifapentine-based regimen
- Where
- 4 sites in Taiwan
- Volunteers
- 333 people
- Sponsor
- Kaohsiung Veterans General Hospital.
Tuberculosis, Tuberculosis, Pulmonary
Feasibility of a Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in South Africa
The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Miliary
- Trial name
- NCT01693224
- Testing
- Alere "Determine" lateral-flow urine lipoarabinomannan assay, Alere "Clearview" ELISA urine LAM assay, Cepheid Xpert MTB/Rif assay
- Where
- 2 sites in South Africa
- Volunteers
- 512 people
- Sponsor
- Tuberculosis Clinical Diagnostics Research Consortium
Pulmonary Tuberculosis
Improving Community Based Tuberculosis Care in Ethiopia
The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome.
- Trial name
- community (NCT00803322)
- Where
- Ethiopia
- Volunteers
- 318 people
- Sponsor
- University of Bergen
Tuberculosis
The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis
The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis.
- Trial name
- NCT00982969
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Armed Forces Capital Hospital, Republic of Korea
Pulmonary TB
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).
- Trial name
- NCT03678688
- Testing
- 10 mg OPC-167832, 30 mg OPC-167832, 90 mg OPC-167832
- Where
- 3 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.