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Shortening Treatment by Advancing Novel Drugs

NCT02342886 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2019-03-26

Study results available
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Summary

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard HRZE treatment.

This study will also assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin, PA-824, and pyrazinamide treatments in DS-TB subjects.

Conditions

  • Tuberculosis, Pulmonary, Drug Sensitive
  • Tuberculosis, Pulmonary, Multi Drug-resistant

Interventions

DRUG

Moxifloxacin

Oral

DRUG

PA-824

Oral

DRUG

Pyrazinamide

Oral

DRUG

HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)

Oral

DRUG

HR (rifampicin plus isoniazid combination tablets)

Oral

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Stephen H Gillespie, MD · University of St Andrews

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-01-31
Completion
2018-05-31

Countries

  • Georgia
  • Kenya
  • Malaysia
  • Philippines
  • South Africa
  • Tanzania
  • Uganda
  • Zambia

Study Locations

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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 NCT02342886 on ClinicalTrials.gov