Clinical trials: Tuberculosis (TB)
- Condition Tuberculosis (TB)
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Tuberculosis Diagnosis
Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children
In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases non-TB participants with lung disease who all meet the standard are divided into different groups through a randomized and blind method.
- Trial name
- NCT03027154
- Testing
- ESAT6-CFP10 in left arm and TB-PPD in right arm, ESAT6-CFP10 in right arm and TB-PPD in left arm
- Where
- 4 sites in China
- Volunteers
- 96 people
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Tuberculosis
Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent.
- Trial name
- NCT03806699
- Testing
- ID93+GLA-SE
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Tuberculosis
Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Phase IV, observational, cohort, prospective study. With duration according to the indicated scheme, 6 months of treatment (2 intensive months and 4 months of sotén) for pulmonary tuberculosis.
- Trial name
- NCT04916899
- Testing
- Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
- Where
- Mexico
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Tuberculosis (TB)
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and…
- Trial name
- MTBVACph2 (NCT06997367)
- Testing
- MTBVAC, BCG Sii
- Where
- 2 sites in India
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Active Tuberculosis, Latent Tuberculosis Infection
Performance Evaluation of the VIDAS TB-IGRA Assay.
This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection.
- Conditions
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- Trial name
- NCT04048018
- Testing
- Blood draw and IGRA test
- Where
- 24 sites in United States, Brazil and 7 more
- Volunteers
- 2,401 people, healthy volunteers welcome
- Sponsor
- BioMérieux
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
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.
Tuberculosis, Pulmonary, Tuberculosis, Extrapulmonary
Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
The goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals suspected to have TB disease.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Extrapulmonary, Tuberculosis Active
- Trial name
- NCT05981495
- Testing
- NanoDetect-TB
- Volunteers
- 460 people
- Sponsor
- NanoPin Technologies, Inc.
Tuberculosis
Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis
Mycobacterium Vaccae for Injection (Trade Name "Vaccae") is a kind of bio-products developed by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,and got "The New Drug Certificate "in 1999.
- Trial name
- NCT01979900
- Testing
- Vaccae
- Where
- 4 sites in China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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.
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents
This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.
- Trial name
- NCT00950612
- Testing
- GSK's investigational vaccine 692342
- Where
- South Africa
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline