Clinical trials: tuberculosis
Tuberculosis, Multidrug-Resistant
Expand New Drugs for TB [endTB]
This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB.
- Trial name
- NCT03259269
- Testing
- This is a non-intervention observational study
- Where
- 16 sites in Armenia, Bangladesh and 12 more
- Volunteers
- 2,804 people
- Sponsor
- Partners in Health
Tuberculosis, Diabetes Mellitus
Immunobiology of Diabetes and Tuberculosis
The study hypothesis is that type 2 diabetics have abnormal cell-mediated immunity to tuberculosis manifesting as altered cytokine responses by peripheral blood mononuclear cells (PBMCs).
- Trial name
- NCT00568854
- Testing
- BCG
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Stanford University
Tuberculosis, Pleural
MTB cfDNA Levels in TBP
Tuberculous pleuritis (TBP) is the most common manifestation of extrapulmonary TB. Its diagnosis is challenging due to the low sensitivity of mycobacterial culture from the pleural fluid and the need for invasive pleural biopsy.
- Trial name
- MYDNITE (NCT05397730)
- Testing
- Mycobacterium tuberculosis (MTB) cell-free DNA (cf-DNA)
- Where
- Hong Kong
- Volunteers
- 329 people
- Sponsor
- Chinese University of Hong Kong
Tuberculosis, Children, Only
Integrating Pediatric TB Services Into Child Healthcare Services in Africa
Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare…
- Conditions
- Tuberculosis, Children, Only, Diagnosis, Delivery of Health Care
- Trial name
- INPUT (NCT03862261)
- Testing
- Integrated pediatric TB services
- Where
- 12 sites in Cameroon, Kenya
- Volunteers
- 1,715 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Tuberculosis
Treatment Adherence of Tuberculosis Medicines
It was hypothesized that tuberculosis patients receiving multiple interventions like educations, counseling and default tracing along with DOTS were more likely to adhere to tuberculosis treatment as compared to few interventions…
- Trial name
- TBAD (NCT01471977)
- Testing
- education,counseling, default tracers,quality of care
- Where
- Pakistan
- Volunteers
- 1,280 people
- Sponsor
- Gambat Institute of Medical Sciences
Tuberculosis, Multidrug-Resistant
Treatment Shortening of MDR-TB Using Existing and New Drugs
The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen…
- Trial name
- MDR-END (NCT02619994)
- Testing
- Linezolid, Delamanid, Levofloxacin
- Where
- South Korea
- Volunteers
- 214 people
- Sponsor
- Seoul National University Hospital
Linezolid, Tuberculosis Multi Drug Resistant Active
Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health. Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023.
- Conditions
- Linezolid, Tuberculosis Multi Drug Resistant Active, Therapeutic Drug Monitoring (TDM)
- Trial name
- PLOT-TB (NCT07477119)
- Testing
- Linezolid dose personalization based on TDM
- Where
- Guinea
- Volunteers
- 150 people
- Sponsor
- Marco Schiuma
Pulmonary Tuberculosis
Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis
The goal of this single-center, open-labelled, clinical trial in two groups aims to proof that a specific group of antibiotics (carbapenems) can be used to treat pulmonary tuberculosis if it is combined with another antibiotic…
- Trial name
- NCT05896930
- Testing
- Meropenem 6g IV over 6 hours, Ertapenem 1g IM, Meropenem 3g IV
- Where
- South Africa
- Volunteers
- 134 people
- Sponsor
- TASK Applied Science
Pulmonology
The Safety, Completion Rate and Prevention Effect by Rifamycin-containing Regimens for Latent Tuberculosis Infection in Patients With Kidney Transplantation: a Prospective Intervention Pilot Study
Tuberculosis (TB) remains the leading infectious disease worldwide and kidney transplant recipients (KTR) is high risk population needing prevention from reactivation, which cause high mortality.
- Trial name
- NCT05588492
- Testing
- Rifamycin-containing regimen, Rifamycin-free regimen
- Where
- Taiwan
- Volunteers
- 500 people
- Sponsor
- National Taiwan University Hospital
Tuberculosis
Evaluation of Four Stool Processing Methods Combined With Xpert MTB/RIF Ultra for Diagnosis of Intrathoracic Paediatric TB (TB-Speed - Stool Processing)
There is a growing interest for the use of stool samples as an alternative to respiratory samples for the diagnosis of intrathoracic TB in children unable to produce sputum.
- Trial name
- NCT04203628
- Testing
- Xpert MTB/Rif Ultra on stool samples, Xpert MTB/Rif Ultra on respiratory sample
- Where
- 3 sites in Uganda, Zambia
- Volunteers
- 215 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Non - Tuberculosis Mycobacteria Lung Disease
NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy
Treatment of non - tuberculosis mycobacteria lung disease is challenging. The current treatment used is from 2007 American Thoracic Society guidelines recommended antibiotic combination therapy, which is lack of validation of…
- Trial name
- NCT03224065
- Testing
- Genotype detected through GenSeizer high-throughput gene capture technology
- Where
- China
- Volunteers
- 246 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Mycobacterium, Cancer
Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not
Non-tuberculous mycobacteria (NTM) are increasingly common and have a poor prognosis: 5-year mortality can reach 40 to 50%, depending on the type of mycobacteria and the immune system of the host involved.
- Conditions
- Mycobacterium, Cancer, Treatment Side Effects
- Trial name
- MYCATRES (NCT05030701)
- Where
- France
- Volunteers
- 41 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Tuberculosis, Meningeal, Tuberculosis; Meningitis (Etiology)
Adjunctive Doxycycline for Central Nervous System Tuberculosis
Although tuberculosis is now considered a treatable disease, central nervous system tuberculosis (CNS-TB) when managed with the current standard-of-care (SOC), still has mortality rates ranging from 30-50% even in tertiary…
- Conditions
- Tuberculosis, Meningeal, Tuberculosis; Meningitis (Etiology), Tuberculosis, Central Nervous System, Tuberculosis; Meningoencephalitis (Etiology)
- Trial name
- DIRECT (NCT06446245)
- Testing
- Doxycycline, Anti Tuberculosis Drug, Adjunctive corticosteroid
- Where
- 6 sites in Indonesia, Malaysia and 1 more
- Volunteers
- 200 people
- Sponsor
- National University Hospital, Singapore
HIV-associated Tuberculosis
Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis
A5406 hypothesized that dolutegravir (DTG) 50 mg taken twice daily provides adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated tuberculosis (TB).
- Trial name
- NCT05630872
- Testing
- Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC, 2HPZM
- Where
- 4 sites in South Africa, Thailand
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Ultra Curto (Ultra Short) TB Prevention Therapy
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
- Trial name
- NCT04703075
- Testing
- Rifapentine 600 mg and INH 300 mg, Rifapentine 900 mg and INH 900 mg
- Where
- 2 sites in Brazil
- Volunteers
- 531 people
- Sponsor
- Johns Hopkins University
Spondyloarthritis
Risk of Tuberculous and Other Infections in Patients of Spondyloarthritis Treated With Tofacitinib in Bangladesh
Treatment failure of Spondyloarthropathies (SpA) leads to marked functional disability, higher rates of morbidity, mortality and poor quality of life.
- Trial name
- NCT03504072
- Testing
- Tofacitinib 5 mg,, Etanercept
- Where
- Bangladesh
- Volunteers
- 174 people
- Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Tuberculosis
Potential Role of Microbiome in Tuberculosis
Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is a deadly infectious disease and major global public health problem.
- Trial name
- Micro-STOP (NCT04985994)
- Where
- 2 sites in Pakistan
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Khyber Medical University Peshawar
Sarcoidosis, Tuberculosis
The Serum Angiotensin Converting Enzyme and Lysozyme Levels in Patients Non-infectious and Infectious Uveitis
This study evaluates the significance of differences in serum angiotensin converting enzyme and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and infectious diseases.
- Trial name
- uveitis (NCT02627209)
- Testing
- spectrophotometric assay, radial immunodiffusion
- Where
- Turkey (Türkiye)
- Volunteers
- 280 people
- Sponsor
- Ozlem Sahin
Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
- Trial name
- NCT03563599
- Testing
- Telacebec (Q203), Rifafour e-275
- Where
- 2 sites in South Africa
- Volunteers
- 60 people
- Sponsor
- Qurient Co., Ltd.
Tuberculosis
Test and Treat TB: A Proof of Concept Trial in South Africa
The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test \& Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this…
- Trial name
- Siyasiza (NCT02298309)
- Testing
- Test-and-Treat TB
- Where
- South Africa
- Volunteers
- 4,815 people
- Sponsor
- Massachusetts General Hospital
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