A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

Beijing Chest Hospital212 enrolled

Overview

The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

212

Conditions

Tuberculosis, Multidrug-Resistant

Interventions

BedaquilineDRUG

Bedaquiline uncoated tablets will be administered orally.

LevofloxacinDRUG

Levofloxacin filmcoated will be administered orally

LinezolidDRUG

Linezolid tablets will be administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has a positive sputum Mycobacterium tuberculosis culture from a test performed at screening * Has microbiological confirmation of rifampicin resistance by GeneXpert and to isoniazid (INH) via molecular drug-susceptibility testing (DST) showing katG mutation * Has a chest imaging result compatible with a diagnosis of pulmonary Tuberculosis (TB) * Agrees to use effective contraception during the 40-week study treatment phase. A female participant must be: of nonchildbearing potential; of childbearing potential and practicing effective methods of contraception during the 40-week study treatment phase * Is willing to undergo human immunodeficiency virus (HIV) testing Exclusion Criteria: * Has received prior treatment with bedaquiline * Has prior exposure to at least 1 second-line drug in the regimen for at least 4 weeks * Has any grade 3 or 4 laboratory abnormality as confirmed by a clinical expert * Has a known allergy or intolerance to bedaquiline or other drugs in the regimen * Is infected with a strain of nontuberculous mycobacteria * Is HIV-positive

Locations (17)

Beijing Chest Hospital

Beijing, China

RECRUITING

The Eighth Medical Center of PLA General Hospital

Beijing, China

Outcomes

Primary Outcomes

Percentage of Participants with a Favorable Treatment Outcome at the End of Treatment

Percentage of participants with a favorable treatment outcome at the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.

Time frame: At the end of treatment (Week 40)

Secondary Outcomes

Percentage of Participants with a Favorable Treatment Outcome at 48 Weeks Post the End of Treatment

Percentage of participants with a favorable treatment outcome at 48 weeks post the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.

Time frame: At 48 weeks post the end of treatment (Week 88)

Percentage of Participants Achieving Treatment Success at the end of Treatment

Percentage of participants achieving treatment success at the end of treatment will be reported. Treatment success is achieved if participants completed their prescribed tuberculosis (TB) treatment; or if their last 3 culture results are negative by the end of treatment, these 3 cultures must be taken on separate visits and should be after the initial 6-month treatment period.

Time frame: At the end of treatment (Week 40)

Percentage of Participants with a Modified Favorable Treatment Outcome at the end of Treatment and at 48 Weeks Post end of Treatment

Percentage of participants with a modified favorable treatment outcome at the end of treatment and at 48 weeks post end of treatment will be reported. A participant's treatment outcome will be classified as modified favorable if their last 2 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 2 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.

Central Contacts

Jingtao Gao, PhD

CONTACT

+8610-89509131 jingtaogao@outlook.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Cycloserine capsules will be administered orally.

ClofazimineDRUG

Clofazimine capsules will be administered orally.

PyrazinamideDRUG

Pyrazinamide tablets will be administered orally.

ProtionamideDRUG

Protionamide enteric-coated tablets will be administered orally.

Changsha Central Hospital

Changsha, China

RECRUITING

Public health clinical medical center of Chengdu

Chengdu, China

RECRUITING

Chongqing Public Health Medical Center

Chongqing, China

RECRUITING

The Pulmonary Hospital of Fuzhou in Fujian Province（The tuberculosis control and prevention Hospital of Fuzhou in Fujian Province）

Fuzhou, China

RECRUITING

Guiyang Public Health Clinical Center

Guiyang, China

RECRUITING

Anhui Chest Hospital

Hefei, China

RECRUITING

Infectious Disease Hospital of Heilongjiang Province

Heilongjiang, China

RECRUITING

Jiamusi Tumor Hospital

Jiamusi, China

NOT_YET_RECRUITING

...and 7 more locations

Time frame: At the end of treatment (Week 40) and at 48 weeks post end of treatment (Week 88)

Percentage of Participants Experiencing All-cause Mortality

Percentage of participants experiencing all-cause mortality will be reported.

Time frame: Up to Week 88

Percentage of Participants Experiencing Grade 3 or Greater Treatment-emergent Adverse Events (TEAEs) During Study Treatment and Follow-up

Percentage of participants experiencing grade 3 or greater TEAEs during study treatment and follow-up will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any event that begins or worsens in severity after initiation of study drug through to the end of study. An assessment of severity grade will be made using the following 5 general categorical descriptors based on division of acquired immunodeficiency syndrome (AIDS) grading for AE severity assessment. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death.

Time frame: During study treatment and follow-up (From Week 1 up to Week 88)

Percentage of Participants Experiencing TEAEs

Percentage of participants experiencing TEAEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any event that begins or worsens in severity after initiation of study drug through to the end of study.

Time frame: From Week 1 up to Week 88

Percentage of Participants with TB Relapses and Re-infections During the Treatment-free Follow-up Phase

Percentage of participants with TB relapses and re-infections during the treatment-free follow-up phase will be reported.

Time frame: During the treatment-free follow-up phase (Up to 48 weeks)

Percentage of Participants Whose Isolates Develop Resistance to Bedaquiline and Other Drugs Used in the Regimen

Percentage of participants whose isolates develop resistance to bedaquiline and other drugs used in the regimen will be reported.

Time frame: Up to Week 88