Clinical trials: tuberculosis
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
Latent Tuberculosis
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
The investigators will conduct a n=5,400 Phase 3, double-blind, individually randomised placebo-controlled clinical trial of 5 years' duration in primary schools in City of Cape Town Metropolitan Municipality, Western Cape…
- Trial name
- ViDiKids (NCT02880982)
- Testing
- Cholecalciferol
- Where
- South Africa
- Volunteers
- 1,743 people, healthy volunteers welcome
- Sponsor
- Queen Mary University of London
Tuberculosis Infection, Healthy Volunteer
Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women
This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in…
- Conditions
- Tuberculosis Infection, Healthy Volunteer, Breastfeeding
- Trial name
- PRiMe (NCT07069582)
- Testing
- Standard dose rifampicin, High dose rifampicin, Standard dose isoniazid
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
TB
Safety, Immunogenicity, and Impact of MVA85A, on the Immunogenicity of the EPI Vaccines
This study is preliminary to proving that this vaccine could protect against tuberculosis in humans. Although there is no proven data to show that infants will benefit directly from participation in this study by being protected…
- Trial name
- NCT00480454
- Testing
- MVA 85A
- Where
- The Gambia
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Renal Impairment, Tuberculosis
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
This is a Phase 1, open-label, single-dose, sequential group study to compare the safety and pharmacokinetics (PK) of pretomanid in the following groups of participants: 1) participants with severe renal impairment including…
- Trial name
- NCT03896750
- Testing
- PA-824
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection
- Trial name
- DAR-PIA (NCT02712424)
- Testing
- DAR-901
- Where
- Tanzania
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center
TB - Tuberculosis
Start4All SCREEN-TB PROTOCOL
Tuberculosis (TB) remains the leading cause of death from a single infectious agent globally, with millions of people still undiagnosed or diagnosed late.
- Trial name
- SCREEN-TB (NCT07517471)
- Testing
- Near point of care (NPOC) NAATs, Low-complexity nucleic acid amplification tests (LC-NAATs), LC-NAAT using pooled testing
- Volunteers
- 37,000 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Latent Tuberculosis Infection (LTBI)
C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia
This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
- Trial name
- C-TST (NCT07587164)
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
- Where
- Indonesia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Latent Tuberculosis, HIV Infections
Improving Latent Tuberculosis (TB) Diagnosis in Thai Children
The study is a prospective study to improve the diagnosis and management of latent TB in HIV-infected and HIV uninfected children in Thailand.
- Trial name
- TB Px (NCT00947609)
- Where
- 2 sites in Thailand
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- SEARCH Research Foundation
Tuberculosis
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the absorption, metabolism, and excretion patterns of a single dose of [14C] PA-824, and (2) the pharmacokinetics, safety, and tolerability of…
- Trial name
- CL-004 (NCT03202693)
- Testing
- PA-824
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Doxycycline in Human Pulmonary Tuberculosis
Pulmonary cavitation, a hallmark of tuberculosis (TB), is the site of high mycobacterial burden leading to disease transmission.
- Trial name
- Doxy-TB (NCT02774993)
- Testing
- Doxycycline
- Where
- Singapore
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National University Hospital, Singapore
Healthy
Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac
This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study to assess the safety, reactogenicity and immunogenicity in healthy, BCG vaccinated adults.
- Trial name
- NCT03878004
- Testing
- GamTBvac vaccine
- Where
- 2 sites in Russia
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Latent Tuberculosis
Determining Risk in Latent Tuberculosis
Background: Tuberculosis (TB) is a leading cause of death worldwide. Those who are exposed to the TB bacteria but have not become sick are said to have latent TB.
- Trial name
- NCT01571739
- Where
- South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Latent Tuberculosis Infection, HIV Infections
Impact of HIV Infection on Latent Tuberculosis (TB) Among Patients With HIV-TB Co-infection
HIV induced altered representation and function of regulatory T cell subsets (NKT and Treg cells) impair the protective T cell response against M.tuberculosis and disrupts LTBI, thus facilitates faster progression and development…
- Conditions
- Latent Tuberculosis Infection, HIV Infections, Tuberculosis
- Trial name
- HIV-TB (NCT00692809)
- Where
- India
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Ministry of Science and Technology, India
Healthy Volunteers
The Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects
The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir.
- Trial name
- NCT03070405
- Testing
- Tenofovir disoproxil fumarate 300mg, Para-aminosalicylic acid Ca granule 5.28 g
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Inje University
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative…
- Trial name
- NCT01424501
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- 6 sites in Estonia, Taiwan
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women
The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832.
- Trial name
- NCT07542847
- Testing
- OPC-167832, Itraconazole, Carbamazepine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Lung Cancer
Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens
The purpose of this study is to study the Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens.
- Trial name
- NCT01322685
- Where
- Taiwan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University WanFang Hospital
Tuberculosis
Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam
The purpose of this study is to determine the safety and tolerability of PA-824 when given with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a clinically important degree as measured by the effect…
- Trial name
- NCT01768273
- Testing
- Midazolam, PA-824
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Latent Tuberculosis
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
- Trial name
- NCT02454738
- Testing
- Ultralow dose chest CT scan
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital