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Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

NCT03086486 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2023-06-29

Study results available
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Summary

To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment intolerant or non-responsive MDR-TB.

Conditions

  • Tuberculosis, Pulmonary
  • Tuberculosis, Multidrug-Resistant
  • Tuberculosis, MDR
  • Tuberculosis
  • Extensively Drug-Resistant Tuberculosis
  • Pre-XDR-TB
  • XDR-TB

Interventions

DRUG

Pretomanid

200mg tablets

DRUG

Linezolid

Scored 600mg tablets

DRUG

Bedaquiline

100mg tablets

DRUG

Placebo Linezolid

Scored 600 mg tablets

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Francesca Conradie · Isango Lethemba TB Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2021-02-15
Completion
2022-02-08
FDA Drug
Yes

Countries

  • Georgia
  • Moldova
  • Russia
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03086486 on ClinicalTrials.gov