Clinical trials: Tuberculosis
Tuberculosis in Children
Impact of an Innovative Childhood TB Diagnostic Approach Decentralized to District Hospital and Primary Health Care Levels on Childhood Tuberculosis Case Detection and Management in High Tuberculosis Incidence Countries (TB-Speed Decentralisation)
The TB-Speed Decentralisation study aims to increase childhood Tuberculosis (TB) case detection at district hospital (DH) and Primary health Care (PHC) levels using adapted and child-friendly specimen collection methods, i.e.
- Trial name
- NCT04038632
- Testing
- Decentralization of Childhood TB Diagnosis
- Where
- 59 sites in Cambodia, Cameroon and 4 more
- Volunteers
- 3,106 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Latent Tuberculosis, Persistent Infection
New Strategies for Assessment of the Persistence of Viable Bacilli in Latent and Active Tuberculosis
Current diagnostic tools such as interferon gamma release assay (IGRA) and purified protein derivative (PPD) can not distinguish patients with latent tuberculosis infection (LTBI) and persistence of live mycobacteria.
- Conditions
- Latent Tuberculosis, Persistent Infection, Mycobacterium Tuberculosis
- Trial name
- TB-LIVE (NCT05621343)
- Where
- Sweden
- Volunteers
- 89 people
- Sponsor
- Region Skane
Tuberculosis
Re-evaluating the Duration in Children of TB Treatment
Current tuberculosis (TB) treatment is effective (works well), but it takes a long time to cure TB. This study will evaluate if TB treatment with a higher dose of rifampicin, one of the TB medicines, and shorter TB treatment…
- Trial name
- REDUCE TB (NCT07656012)
- Testing
- Rifampicin, Isoniazid, Pyrazinamide
- Where
- Peru
- Volunteers
- 230 people
- Sponsor
- University of Wisconsin, Madison
Tuberculosis, Rifampicin Resistant Tuberculosis
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with…
- Trial name
- NCT05586230
- Testing
- Pretomanid, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)
- Where
- 5 sites in Brazil, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia
The goal of this cluster-randomised controlled trial (CRCT) is to learn whether the use of new non-sputum-based diagnostic tests and other intervention components for tuberculosis (TB) diagnosis in healthcare facilities (HCF) can…
- Trial name
- EVIDENT (NCT07293455)
- Testing
- nPOC Testing Intervention Package
- Where
- Indonesia
- Volunteers
- 40,000 people
- Sponsor
- Universitas Padjadjaran
Tuberculosis, Pulmonary
Digital Health Intervention to Improve TPT Uptake
Despite the evidence of the prevention and control measures of tuberculosis (TB), it still has an impact on the health, social, and economic aspects of the population.
- Trial name
- DHiTPT (NCT07313995)
- Testing
- Digital health intervention
- Where
- 14 sites in Ethiopia
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Arba Minch University
Tuberculosis, Pulmonary
Study of Combinations of Novel Promising Drugs for Pulmonary Tuberculosis
A phase 2, two-part, multicentre, open label, controlled, randomised clinical trial in adult participants with newly diagnosed, sputum-positive pulmonary drug-sensitive tuberculosis (DSTB).
- Trial name
- SYNERGY (NCT07773610)
- Testing
- TBAJ-587 50 mg, Pretomanid 200mg, Linezolid 600Mg Tab
- Where
- South Africa
- Volunteers
- 135 people
- Sponsor
- TASK Applied Science
TB - Tuberculosis, HIV - Human Immunodeficiency Virus
Integrating Tuberculosis Treatment Into Community Pharmacies to Improve TB/HIV Outcomes in Uganda
Community pharmacies (CPs) have emerged as promising differentiated service delivery models for refilling antiretroviral therapy (ART) among people with human immunodeficiency virus (HIV).
- Trial name
- NCT07840651
- Testing
- The intervention is TB treatment delivery via community pharmacies for people with TB/HIV, Control Arm - standard of care
- Where
- 2 sites in Uganda
- Volunteers
- 124 people
- Sponsor
- Makerere University
Tuberculosis (TB)
Usability mTBScreen
Building on recent developments in the sphere of digital health and data science, as well as the principles of usability engineering, we propose to assess the usability of a digital tool called mTBscreen for tuberculosis (TB)…
- Trial name
- mTBscreen (NCT07840989)
- Testing
- mTBscreen Application, Mobile phone Application
- Where
- 4 sites in Zambia
- Volunteers
- 30 people
- Sponsor
- Centre for Infectious Disease Research in Zambia
Tuberculosis, HIV
Validation of a Tuberculosis Treatment Decision Algorithm in HIV-infected Children (TB-Speed HIV)
TB-Speed HIV is a prospective multicentre management study evaluating the safety and feasibility of the recently proposed PAANTHER TB treatment decision algorithm for HIV-infected children with presumptive TB.
- Trial name
- NCT04121026
- Testing
- External validation of the PAANTHER TB treatment decision algorithm
- Where
- 7 sites in Côte d’Ivoire, Mozambique and 2 more
- Volunteers
- 278 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Tuberculosis, Multidrug-Resistant
Bioneer Q-RFIA Clinical Evaluation
Robust evidence on the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is required to comprehensively evaluate validity of the Bioneer RFIA assay to support both…
- Trial name
- NCT05117788
- Testing
- Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac
- Where
- 5 sites in Kenya, Moldova and 3 more
- Volunteers
- 2,350 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Pneumonia, Tuberculosis, Pulmonary
The LalelaLung Study: Digital Stethoscope Clinical Evaluation
Pneumonia is the leading infectious cause of death in children under five years of age worldwide, and most of these deaths occur in low- and middle-income countries.
- Conditions
- Pneumonia, Tuberculosis, Pulmonary, Respiratory Tract Infections, Bronchiolitis
- Trial name
- LaLeLa (NCT07631377)
- Testing
- StethoMe AI-enabled digital stethoscope system, Standard IMCI assessment
- Volunteers
- 350 people
- Sponsor
- Johns Hopkins University
Tuberculosis, Pulmonary, Tuberculosis Infection
Short-course Regimens for the Treatment of Pulmonary Tuberculosis
The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as…
- Trial name
- CRUSH-TB (NCT05766267)
- Testing
- Rifabutin, Delamanid, Bedaquiline
- Where
- 8 sites in United States, Canada and 4 more
- Volunteers
- 288 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis, Pulmonary
Fibroblast Activating Protein (FAP) PET/CT in Adults With Tuberculosis
This is an early phase study in patients with Tuberculosis (TB) to evaluate Fibroblast Activating Protein (FAP) activation as a marker of fibrosis.
- Trial name
- NCT07830771
- Testing
- [18F]-FAPI-74
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Pennsylvania
Tuberculosis, Multidrug-Resistant
Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less…
- Trial name
- NCT02354014
- Testing
- Bedaquiline (TMC207), Background Regimen (BR)
- Where
- 11 sites in Mozambique, Philippines and 4 more
- Volunteers
- 60 people
- Sponsor
- Janssen Research & Development, LLC
Tuberculosis
Improve Treatment Outcomes for Tuberculosis Infection in Tertiary Care Hospitals
Early diagnosis can contribute to good treatment outcomes and isolate infection control.
- Trial name
- NCT03042754
- Testing
- XpertMTB/RIF
- Where
- 4 sites in Thailand
- Volunteers
- 150 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Tuberculosis, Pulmonary
Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients
The 4-month daily regimen containing moxifloxacin (2HRZEM 7 / 2HRM7) of ICMR-NIRT was studied in 321 sputum positive pulmonary TB patients in a randomised clinical trial.
- Trial name
- NCT05047055
- Testing
- Isoniazid, Rifampicin, Pyrazinamide
- Where
- India
- Volunteers
- 550 people
- Sponsor
- Tuberculosis Research Centre, India
Lung Cancer, Tuberculosis (TB)
Effectiveness of Chat-based Mobile Application for Consultation (Zalo) in Improving Compliance With Follow-up Tests After Abnormal Chest X-ray Findings Interpret by Artificial Intelligent
The study titled "Effectiveness of Chat-based Mobile Application for Consultation (Zalo) in Improving Compliance with Follow-up Tests after Abnormal Chest X-ray Findings Interpreted by Artificial Intelligence" aims to evaluate…
- Conditions
- Lung Cancer, Tuberculosis (TB), Chat-based Mobile Application, Compliance Behavior
- Trial name
- NCT07234929
- Testing
- chat-based mobile application (Zalo)
- Where
- Vietnam
- Volunteers
- 2,692 people, healthy volunteers welcome
- Sponsor
- Gia Dinh People Hospital
MDR-TB, Tuberculosis Multi Drug Resistant Active
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
The FAST-MDR trial is an externally-controlled, multicentre trial with one prospective arm, evaluating the non-inferiority of the effectiveness of BPaLM in the interventional arm versus the effectiveness of the long, conventional…
- Conditions
- MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance, Mycobacterium Tuberculosis
- Trial name
- FAST-MDR (NCT07486024)
- Testing
- Bedaquiline Oral Tablet
- Where
- 5 sites in France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years.
- Trial name
- NCT07762014
- Testing
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Where
- Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Biothervax SpA