Clinical trials: Mycobacterium Tuberculosis
Tuberculosis (TB)
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
- Trial name
- NCT00730795
- Testing
- GSK's candidate Mycobacterium tuberculosis vaccine 692342
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Evaluation of Efficacy and Safety of the Concomitant of RUTI® Immunotherapy With the Standard Treatment in TB Patients
The study is an exploratory clinical trial to evaluate the efficacy and safety of the treatment with a vaccine against tuberculosis (RUTI®) given at the same time as standard treatment in patients with tuberculosis.
- Trial name
- CONSTAN (NCT05136833)
- Testing
- RUTI® vaccine
- Sponsor
- Archivel Farma S.L.
Infections, Human Immunodeficiency Virus and Tuberculosis
A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects
The current study is designed to confirm the mechanism behind the increase in serum creatinine observed during GSK1349572 therapy; specifically, the study will determine whether GSK1349572 has any effect on glomerular filtration…
- Trial name
- NCT01214993
- Testing
- GSK1349572, Iohexol Injection, Para-aminohippurate infusion
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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.
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, Tuberculosis Vaccines
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo.
- Trial name
- NCT01755598
- Testing
- GSK Biologicals' investigational TB vaccine (GSK692342)
- Where
- 9 sites in Kenya, South Africa and 1 more
- Volunteers
- 3,575 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
- Trial name
- NCT02253537
- Testing
- CST001
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Multidrug-Resistant
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB)…
- Trial name
- NCT02365623
- Testing
- TMC207 (bedaquiline), Background Regimen (BR)
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Janssen Pharmaceutical K.K.
Latent Tuberculosis Infection
Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above
A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other…
- Trial name
- NCT05899179
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein, Purified Protein Derivative of Tuberculin
- Where
- 8 sites in China
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Pulmonary Tuberculosis
Study on the Use of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
The purpose of this study is to evaluate the efficacy and tolerability of the complex therapy of drug-resistant respiratory tuberculosis using the drug Ingaron, a lyophilisate for the preparation of a solution for injection for…
- Trial name
- NCT05359315
- Testing
- Interferon-Gamma
- Where
- Russia
- Volunteers
- 84 people
- Sponsor
- SPP Pharmaclon Ltd.
Tuberculosis, HIV
TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer
The purpose of this Phase I, open-label, randomized crossover trial is to investigate the pharmacokinetic interaction between steady-state lopinavir/ritonavir and single-dose TMC207 in healthy volunteers.
- Trial name
- NCT00828529
- Testing
- TMC207
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Tibotec BVBA
Tuberculosis, Healthy
Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for residents in endemic areas and persons at…
- Trial name
- NCT00749034
- Testing
- VPM1002, BCG
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Multidrug-resistant Tuberculosis
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.
- Trial name
- NCT01424670
- Testing
- Delamanid + OBR
- Where
- 17 sites in Estonia, Latvia and 5 more
- Volunteers
- 511 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Dovprela
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
Dovprela Tablets (Pretomanid) is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale. This non-interventional post-marketing surveillance (PMS) study is one of the obligations that must…
- Trial name
- NCT06471088
- Testing
- Dovprela
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Viatris Inc.
Tuberculosis, TB Infection
A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia
- Trial name
- NCT07647107
- Testing
- LipovaxinS4-EAH (Middle Dose), LipovaksinS4-EAH (High Dose)
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Rifampin-Resistant Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant (MDR-TB)
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant…
- Trial name
- WISH (NCT05824871)
- Testing
- Sudapyridine, Bedaquiline
- Where
- 2 sites in China
- Volunteers
- 450 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Tuberculosis, Multidrug-Resistant
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible.
- Trial name
- NCT02573350
- Testing
- Delamanid, OBR
- Where
- 8 sites in China, Estonia and 4 more
- Volunteers
- 213 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa
Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis…
- Trial name
- NCT02391415
- Testing
- VPM1002, BCG, VPM1002(Hyg+)
- Where
- 4 sites in South Africa
- Volunteers
- 416 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.