Clinical trials: Mycobacterium Tuberculosis Infection
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)
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults
This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in healthy European volunteers who are PPD-positive either via previous vaccination with BCG and/or conversion to PPD positivity through…
- Trial name
- NCT00146744
- Testing
- Mtb72F/AS02A
- Where
- Switzerland
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis (TB)
Assessing the Ability of the T-SPOT®.TB Test
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response in identifying patients with active TB disease.
- Trial name
- IQ (NCT03929705)
- Where
- South Africa
- Volunteers
- 676 people
- Sponsor
- Oxford Immunotec
Tuberculosis
PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay
PNU-100480 is being developed for the treatment of both drug resistant and sensitive tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480 when given for 14 days to treatment-naive patients…
- Trial name
- NCT01225640
- Testing
- PNU-100480, RHZE
- Where
- 2 sites in South Africa
- Volunteers
- 59 people
- Sponsor
- Sequella, Inc.
Tuberculosis
Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.
- Trial name
- NCT00871949
- Testing
- PNU-100480
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Sequella, Inc.
Healthy
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.
- Trial name
- NCT01999231
- Testing
- ESAT6-CFP10
- Volunteers
- 32 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
- NCT02256839
- Testing
- CST_001
- Where
- United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Tuberculosis
An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Tuberculosis remains a concerning health problem, with Mycobacterium Tuberculosis (MTB) now causing more deaths than acquired immune deficiency syndrome (AIDS).
- Trial name
- NCT03557281
- Testing
- GSK3036656, Rifafour e-275
- Where
- South Africa
- Volunteers
- 76 people
- Sponsor
- GlaxoSmithKline
Infection, Human Immunodeficiency Virus, HIV Infections
Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection
HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide.
- Trial name
- NCT02178592
- Testing
- DTG 50 mg, EFV 600 mg
- Where
- 28 sites in Argentina, Brazil and 5 more
- Volunteers
- 113 people
- Sponsor
- ViiV Healthcare
Tuberculosis
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days.
- Trial name
- NCT00990990
- Testing
- PNU-100480, Linezolid
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Sequella, Inc.
Tuberculosis Identification.
Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)
A study to determine bioequivalence of PPD material versus Reference Standard.
- Trial name
- 02 (NCT01798121)
- Testing
- To compare new PPD to reference standard material, Reference standard
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- JHP Pharmaceuticals LLC
Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis, Mycobacterial Pneumonia, Mycobacterium Abscessus Infection
- Trial name
- NCT04685720
- Testing
- LungFit
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Beyond Air Inc.
Pulmonary Tuberculosis
Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis
Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis
- Trial name
- NCT02467608
- Testing
- Isoniazid with HUEXC030 and RZE, HRZE
- Where
- 18 sites in Taiwan
- Volunteers
- 557 people
- Sponsor
- Orient Pharma Co., Ltd.
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.
Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.