Clinical trials: Phthisis
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
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
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
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.
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
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.
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
Lung Tuberculosis, MDR TB
Tuberculosis Research of INA-RESPOND On Drug Resistance
This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray…
- Trial name
- TRIPOD (NCT02758236)
- Testing
- No Intervention
- Where
- 7 sites in Indonesia
- Volunteers
- 490 people
- Sponsor
- Ina-Respond
Tuberculosis
Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects
This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for pulmonary TB.
- Trial name
- NCT01587469
- Where
- United States
- Volunteers
- 992 people
- Sponsor
- Cepheid
Pulmonary Tuberculosis
Rosuvastatin Evaluation as a Tuberculosis Treatment Adjunct
This trial aims to determine whether the addition of rosuvastatin to standard TB therapy in pulmonary tuberculosis results in accelerated of sputum culture conversion.
- Trial name
- ROSETTA (NCT04504851)
- Testing
- Rosuvastatin 10mg, Rifampicin, Isoniazid
- Where
- 6 sites in Philippines, Singapore and 2 more
- Volunteers
- 154 people
- Sponsor
- National University Hospital, Singapore
Pulmonary TB, Pulmonary Tuberculosis
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult…
- Conditions
- Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
- Trial name
- NCT06058299
- Testing
- sorfequiline, Pretomanid, Linezolid
- Where
- 22 sites in Georgia, Philippines and 3 more
- Volunteers
- 309 people
- Sponsor
- Global Alliance for TB Drug Development