Multi-drug Resistant Tuberculosis Clinical Trial
Official title:
A Phase III Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy and Safety of TMC207 in Subjects With Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB)
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2022 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosed with sputum smear-positive pulmonary Mycobacterium multi-drug resistant tuberculosis; including pre-extensively drug resistant TB, and positive for acid fast bacilli on direct smear examination of expectorated or induced sputum specimen (>=1+ smear positive within the preceding 3 weeks) at screening and also on Day -1 Exclusion Criteria: - Has known infection with extensively drug resistant tuberculosis isolate - Has a clinically significant active medical condition such as, but not limited to, hepatic, pancreatic, renal, cardiovascular, gastrointestinal, hematologic, neurologic, locomotor, immunologic, ophthalmologic (e.g., corneal opacification or ulcers, uveitis, chorioretinitis), metabolic (except stable diabetes based on the investigator's judgement), endocrine, oncological disease, muscular disease (e.g., myositis, rhabdomyolysis), or psychiatric, dermatological illness, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results. Eligibility of patients with poorly controlled diabetes as indicated by hemoglobin A1c higher than the normal range at screening should be based on the investigators judgment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Infectious Diseases BVBA |
Brazil, Cambodia, China, Estonia, Ethiopia, Georgia, Korea, Republic of, Latvia, Mexico, Peru, Philippines, Russian Federation, South Africa, Taiwan, Thailand, Turkey, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with favorable treatment outcome at Week 60 | Week 60 | No | |
Secondary | Number of patients with confirmed culture conversion at Week 84 | Week 84 | No | |
Secondary | Number of patients with confirmed culture conversion at Week 60 or at time of trial discontinuation | Up to Week 132 | No | |
Secondary | The number of patients with development of pre-extensively drug-resistant tuberculosis and extensively drug-resistant tuberculosis | Up to Week 132 | No | |
Secondary | Time to sputum culture conversion | Up to Week 132 | No | |
Secondary | Number of patients with negative culture and smear for tuberculosis | Up to Week 132 | No | |
Secondary | Time to positive signal in Mycobacteria Growth Indicator Tube (MGIT960) | Up to Week 132 | No | |
Secondary | Number of patients with confirmed culture conversion by lung cavity status | Up to Week 132 | No | |
Secondary | Number of patients with confirmed culture conversion by geographic region | Up to Week 132 | No | |
Secondary | Number of patients with confirmed culture conversion by human immunodeficiency virus status | Up to Week 132 | No | |
Secondary | Number of patients with confirmed culture conversion by baseline resistance to anti-tuberculosis therapy | Up to Week 132 | No | |
Secondary | Number of patients with Tuberculosis Symptom Profile symptoms at Week 36 and at the end of the treatment-free follow up | Up to Week 132 | No | |
Secondary | Number of tuberculosis-related deaths per investigator assessment | Up to Week 132 | Yes | |
Secondary | Number of patients with weight gain (greater than 5 percent) at Week 36 and at the end of the treatment-free follow up | Up to Week 132 | No | |
Secondary | Number of patients with improvements in laboratory assessments at Week 36 and at the end of the treatment-free follow up | Up to Week 132 | Yes | |
Secondary | Number of patients with improvements in chest radiograph assessments at Week 36 and at the end of the treatment-free follow up | Up to Week 132 | No | |
Secondary | Number of patients that received salvage regimen with favorable treatment outcome 24 weeks after the end of the individualized salvage regimen | Up to Week 132 | No | |
Secondary | Mean plasma concentrations of TMC207 | Up to Week 36 | No | |
Secondary | Mean plasma concentrations of N-monodesmethyl metabolite of TMC207 | Up to Week 36 | No | |
Secondary | Number of patients affected by an adverse event | Up to Week 132 | Yes | |
Secondary | Number of patients with confirmed culture conversion at Week 36 | Up to Week 132 | No | |
Secondary | Number of patients who required lung surgeries (resection or pneumonectomy) during the study | Week 84 | No | |
Secondary | Number of patients with confirmed culture conversion by baseline albumin grade | Up to Week 132 | No | |
Secondary | Number of patients with confirmed culture conversion by baseline TMC207 minimal inhibitory concentration | Minimal inhibitory concentration is defined as lowest concentration of an antimicrobial agent that will inhibit the visible growth of an organism. | Up to Week 132 | No |
Secondary | Number of patients with confirmed culture conversion at Week 132 | Week 132 | No | |
Secondary | Number of patients who required lung surgeries (resection or pneumonectomy) during the study | Week 132 | No | |
Secondary | Number of patients who experienced death | Up to Week 132 | Yes | |
Secondary | Number of patients will be qualified as cure based on the WHO outcome definition and the number of treatment failures, deaths, transfer out/defaults, and treatment completed | Cure is defined as an multidrug-resistant tuberculosis (MDR-TB) patient who has completed the study procedures according to the protocol and has at least five consecutive negative cultures from samples collected at least 30 days apart in the final 12 months of the study. If only one positive culture is reported during that time, a patient may still be considered cured, provided that this positive culture is followed by a minimum of 3 consecutive negative cultures taken at least 30 days apart. Treatment failure is defined as a patient who completed the study procedures and was not cured as per the "Cure" definition based on the WHO classification during the study procedures. Defaults is defined as patients who discontinued study procedures for any reason. Treatment completed is defined as an MDR-TB patient who has completed the study procedures but does not meet the definition for cure or treatment failure due to lack of bacteriologic results. | Up to Week 132 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03057756 -
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
|
||
Completed |
NCT04207112 -
Economic Evaluation of New MDR TB Regimens
|
Phase 2/Phase 3 | |
Completed |
NCT03000517 -
PK of Levofloxacin in MDR-TB Patients
|
N/A | |
Completed |
NCT03470233 -
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
|
||
Completed |
NCT03830671 -
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
|
Phase 4 | |
Recruiting |
NCT03575299 -
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells
|
Phase 1 | |
Recruiting |
NCT03827811 -
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
|
||
Completed |
NCT04342598 -
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
|
||
Completed |
NCT04309656 -
A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid
|
Phase 1 | |
Completed |
NCT03822156 -
Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
|
||
Completed |
NCT00425113 -
Metronidazole for Pulmonary Tuberculosis (South Korea)
|
Phase 2 | |
Active, not recruiting |
NCT04081077 -
PRACTECAL-PKPD Sub Study
|
Phase 2/Phase 3 | |
Recruiting |
NCT04397536 -
New Genomic Techniques and Management of Multidrug-resistant Tuberculosis
|
||
Completed |
NCT00691392 -
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
|
Phase 1/Phase 2 | |
Completed |
NCT00664313 -
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
|
Phase 1/Phase 2 |