Clinical trials: Mycobacterium Infections
Multi-drug Resistant Tuberculosis
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
- Trial name
- NCT01600963
- Testing
- Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207, Treatment Failure During Follow-up Phase: TMC207
- Where
- 44 sites in Brazil, Cambodia and 15 more
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
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, Pulmonary
Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis
This study is proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with pulmonary tuberculosis. Therapeutic vaccination of RUTI would stimulate the immune response not only against growing bacteria, but…
- Trial name
- CONSTAN-ARG (NCT05455112)
- Testing
- RUTI® Vaccine
- Where
- 2 sites in Argentina
- Volunteers
- 41 people
- Sponsor
- Archivel Farma S.L.
Tuberculosis
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65
The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and…
- Trial name
- IIb-healthy (NCT02389322)
- Testing
- 5μg/ml ESAT6-CFP10, 10μg/ml ESAT6-CFP10, BCG
- Where
- China
- Volunteers
- 1,044 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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
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 objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4…
- Trial name
- NCT00002267
- Testing
- Rifabutin
- Where
- 43 sites in United States, Canada
- Volunteers
- 750 people
- Sponsor
- Pharmacia
Tuberculosis, Pulmonary
MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB. Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.
- Trial name
- NCT00495339
- Testing
- Levofloxacin
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Sanofi
Tuberculosis, Pulmonary
Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.
To determine the pharmacokinetics of ethionamide (Eto) and ethionamide-sulfoxide (Eto-SO) in participants with tuberculosis (TB) when Eto is dosed under programmatic conditions.
- Trial name
- NCT05258877
- Testing
- Plasma samples
- Where
- South Africa
- Volunteers
- 30 people
- Sponsor
- BioVersys AG
Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by…
- Conditions
- Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection
- Trial name
- NCT04922554
- Testing
- Omadacycline Oral Tablet
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- Paratek Pharmaceuticals Inc
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.
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
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
Mycobacterium Avium-intracellular Infection, HIV Infections
The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.
- Trial name
- NCT00002336
- Testing
- Clarithromycin
- Where
- 22 sites in United States
- Sponsor
- Abbott
Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2.
- Trial name
- NCT05496374
- Testing
- SPR720 500 mg, SPR720 1000 mg
- Where
- 28 sites in United States
- Volunteers
- 25 people
- Sponsor
- Spero Therapeutics
Tuberculosis
Phase 2a Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Healthcare Workers
The purpose of this study is to evaluate the experimental tuberculosis (TB) vaccine called ID93+GLA-SE. The safety, immunogenicity, and efficacy of ID93+GLA-SE will be compared to placebo, after three intramuscular (IM)…
- Trial name
- NCT03806686
- Testing
- ID93+GLA-SE
- Where
- 3 sites in South Korea
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
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.
Tuberculosis
A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double…
- Trial name
- NCT04239313
- Testing
- Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Mycobacterium Infections, Nontuberculous
Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease
A prospective, single-center, single-blinded study involving patients with refractory nontuberculous mycobacteria lung disease to ascertain pharmacokinetics, safety, efficacy, and tolerability of two dose levels of parenteral…
- Trial name
- IMPULSE-7 (NCT04154826)
- Testing
- Recombinant human interleukin-7
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Revimmune
Melanoma
A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.
- Trial name
- NCT01308762
- Testing
- Heat killed whole cell M. obuense (IMM-101) 0.1 mg, Heat-killed whole cell M.obuense (IMM-101) 0.5 mg, Heat killed whole cell M.obuense (IMM-101) 1.0 mg
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Immodulon Therapeutics Ltd