Clinical trials: Mycobacterium
Tuberculosis
A Phase ⅠStudy of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
There are four populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried (AEC/BC02) phase I clinical research. The clinical study adopt open research design.
- Trial name
- AEC/BC02 (NCT03026972)
- Testing
- Low dose adjuvant, High dose adjuvant, Low dose vaccine
- Where
- China
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI…
- Trial name
- MTBVAC-Ph1b (NCT02729571)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Pulmonary Tuberculosis
A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
- Trial name
- NCT02836483
- Testing
- LCB01-0371 800mg, QD, LCB01-0371 400mg, BID, LCB01-0371 800mg, BID
- Where
- South Korea
- Volunteers
- 79 people
- Sponsor
- LigaChem Biosciences, Inc.
Tuberculosis, Pulmonary
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
- Trial name
- NCT05899400
- Testing
- Diascopic iON Image Analysis System
- Where
- Uganda
- Volunteers
- 400 people
- Sponsor
- Diascopic, LLC
Mycobacterium Avium-intracellulare Infection, HIV Infections
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200…
- Trial name
- NCT00002032
- Testing
- Rifabutin
- Where
- 33 sites in United States
- Volunteers
- 750 people
- Sponsor
- Pharmacia
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
Tuberculosis
Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above
This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above.
- Trial name
- NCT07152639
- Testing
- 5μg/ml EEC, 5 unit（U） EC, 5 IU TB-PPD
- Where
- 8 sites in China
- Volunteers
- 1,784 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
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
Phase I Clinical Protocol of BCG-PPD in Healthy People
A total of 80 healthy people aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected…
- Trial name
- NCT04593771
- Testing
- BCG-PPD
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and ethambutol (EB) in adult participants with…
- Trial name
- NCT04630145
- Testing
- Bedaquiline, Clarithromycin, Ethambutol
- Where
- 55 sites in Japan, South Korea and 1 more
- Volunteers
- 129 people
- Sponsor
- Janssen Pharmaceutical K.K.
Tuberculosis, Pulmonary
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to…
- Trial name
- NCT04919239
- Testing
- RUTI®
- Where
- 2 sites in India
- Volunteers
- 140 people
- Sponsor
- Archivel Farma S.L.
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
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
Tuberculosis Vaccine in Healthy Indian Adults
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and…
- Trial name
- BBV169/2023 (NCT06438978)
- Testing
- Tuberculosis Vaccine
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
- Trial name
- NCT04553406
- Testing
- SPR720, Open-label Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- Spero Therapeutics
Tuberculosis, MDR
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance.
- Trial name
- FS-1 (NCT02607449)
- Testing
- FS-1
- Where
- 6 sites in Kazakhstan, Kyrgyzstan
- Volunteers
- 344 people
- Sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan
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
Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers
This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis.
- Trial name
- NCT01585636
- Testing
- SQ109
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Sequella, Inc.
Latent Tuberculosis Infection
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients.
- Trial name
- NCT05746611
- Testing
- Recombinant Mycobacterium tuberculosis fusion protein for injection, TB-PPD was injected
- Where
- China
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis (TB)
QuantiFERON Access Clinical Performance Study Protocol
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Trial name
- NCT04243031
- Testing
- QFT Access
- Volunteers
- healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc