Clinical trials: Mycobacterial Disease
Tuberculosis, Latent Tuberculosis
Prognostic Value of Interferon Gamma Release Assays in Predicting Active Tuberculosis Among Individuals With, or at Risk of, Latent Tuberculosis Infection
The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test (Mantoux Tuberculin Skin Test (TST)), for…
- Trial name
- PREDICT (NCT01162265)
- Where
- 3 sites in United Kingdom
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Public Health England
Tuberculosis
Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?
The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks.
- Trial name
- NCT00146302
- Testing
- Bacille Calmette Guerin (BCG)
- Where
- Guinea-Bissau
- Volunteers
- 2,320 people
- Sponsor
- Bandim Health Project
Mycobacterium Avium-intracellular Infection, HIV Infections
The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).
- Trial name
- NCT00002331
- Testing
- Ethambutol hydrochloride, Clarithromycin, Clofazimine
- Where
- 18 sites in United States, Puerto Rico
- Sponsor
- Abbott
Immune Reconstitution Inflammatory Syndrome, Immune Reconstitution Syndrome
Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial
Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution…
- Conditions
- Immune Reconstitution Inflammatory Syndrome, Immune Reconstitution Syndrome, Tuberculosis, HIV-infection/Aids
- Trial name
- NCT01442428
- Testing
- Dexamethasone, Atorvastatin, Naproxen
- Where
- 3 sites in Thailand
- Sponsor
- University of Minnesota
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
Tuberculosis
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI…
- Trial name
- MTBVAC-Ph1b (NCT02729571)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Tuberculosis
Tuberculosis (TB) Immunotherapy Phase 2 Study
This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum…
- Trial name
- imm02 (NCT01380119)
- Testing
- V7
- Where
- Ukraine
- Volunteers
- 40 people
- Sponsor
- Lisichansk Regional Tuberculosis Dispensary
Latent Tuberculosis
Latent Tuberculosis Infection in Korean Health Care Workers
The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers.
- Trial name
- NCT03010111
- Testing
- QFT-IT Test and other blood sampling
- Where
- South Korea
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Hanyang University
Pulmonary Tuberculosis
A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
The objective of the investigator's study is to detect the characteristics, pattern and outcome of pulmonary tuberculosis patients treated at Assiut University Hospital by collecting their demographic, clinical, laboratory and…
- Trial name
- NCT04055441
- Volunteers
- 60 people
- Sponsor
- Assiut University
HIV, Tuberculosis
Preliminary Evaluation of a Point-Of-Care Liver Function Test
The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase test with the standard of care test used in an HIV clinic at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.
- Conditions
- HIV, Tuberculosis, Drug-Induced Liver Injury
- Trial name
- DFA (NCT01705041)
- Testing
- Diagnostics for All liver function test (LFT)
- Where
- Vietnam
- Volunteers
- 700 people
- Sponsor
- PATH
Leprosy, Buruli Ulcer
Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia
Appropriate targeting of interventions for neglected tropical diseases (NTDs) that require innovative and intensified disease management (IDM) requires accurate data on the distribution of these diseases within endemic countries.
- Conditions
- Leprosy, Buruli Ulcer, Yaws, Lymphatic Filariases
- Trial name
- NCT03683745
- Where
- Liberia
- Volunteers
- 56,285 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Leprosy
Leprosy Skin Test Antigens Phase 1
This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae.
- Trial name
- NCT01920750
- Testing
- MLCwA, MLSA-LAM, Mock Antigen
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2.
- Trial name
- NCT05496374
- Testing
- SPR720 500 mg, SPR720 1000 mg
- Where
- 28 sites in United States
- Volunteers
- 25 people
- Sponsor
- Spero Therapeutics
Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation
Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
The goal of this observational study is to support U.S. healthcare centers in determining if they may have an NTM outbreak among patients receiving care at the healthcare center.
- Conditions
- Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation, Healthcare Associated Infection, Mycobacterium Infections
- Trial name
- TrANsMIt (NCT06155747)
- Testing
- Epidemiologic investigation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of North Carolina, Chapel Hill
Pleural Effusion, Tuberculosis, Pleural
A Prospective Observational Study on the Role of Transthoracic Ultrasound in Differentiating Tuberculous From Malignant Pleural Effusion
Primary Endpoint To assess the prevalence and diagnostic performance of pre-determined echographic features in predicting the diagnosis of TBE from MPE.
- Conditions
- Pleural Effusion, Tuberculosis, Pleural, Malignant Pleural Effusion
- Trial name
- TUS-TBE (NCT05935696)
- Where
- Malaysia
- Volunteers
- 100 people
- Sponsor
- Sarawak General Hospital
Mycobacterium Abscessus Infection
Epetraborole in Patients With Mycobacterium Abscessus Lung Disease
This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus…
- Trial name
- REBOUND (NCT07301320)
- Testing
- Epetraborole
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Kevin Winthrop
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis
PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Bacterial Infections, Mycobacterial Infection
- Trial name
- NCT04783727
- Testing
- Individualised treatment duration based on RNA transcriptomic model
- Where
- 5 sites in Germany, Moldova and 2 more
- Volunteers
- 4 people
- Sponsor
- Research Center Borstel
Pulmonary Tuberculosis
Pharmacokinetic Study of Patients Who Undergo Cycloserine, a 2nd-line Antituberculosis Medicament
In all treatments of tuberculosis, the second-line drugs are usually less effective but have more drug toxicity than the first-line ones.
- Trial name
- CSPK (NCT01002170)
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Taipei Medical University WanFang Hospital
Tuberculosis, Multidrug Resistant Tuberculosis
An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis
This study aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional…
- Conditions
- Tuberculosis, Multidrug Resistant Tuberculosis, Extensively-drug Resistant Tuberculosis
- Trial name
- NEXT (NCT02454205)
- Testing
- Linezolid, Bedaquiline, Levofloxacin
- Where
- South Africa
- Volunteers
- 154 people
- Sponsor
- University of Cape Town
Tuberculosis
Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients
This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).
- Trial name
- NCT02169141
- Testing
- Pharmacokinetics
- Where
- Belarus
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen