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A Randomised Trial to Evaluate Toxicity and Efficacy of 1200mg and 1800mg Rifampicin for Pulmonary Tuberculosis

NCT02581527 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 672

Last updated 2023-04-27

No results posted yet for this study

Summary

In this trial, the investigators are assessing whether giving an increased dose of rifampicin to patients receiving the standard treatment for tuberculosis is safe and, when given for 4 months only, will also result in greater and faster killing of the tubercle bacillus in the lungs and result in relapse rates similar to those found in the World Health Organisation (WHO) recommended standard 6 month regimen.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

Rifampicin

Rifampicin 150mg (Control arm); Rifampicin 1200mg (Regimen 1); Rifampicin 1800mg (Regimen 2)

DRUG

Isoniazid

Isoniazid 75mg - all arms

DRUG

Ethambutol

Ethambutol 275mg - all arms

DRUG

Pyrazinamide

Pyrazinamide 400mg - all arms

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • University of Botswana

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Amina Jindani, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2022-01-01
Completion
2022-07-31

Countries

  • Botswana
  • Guinea
  • Nepal
  • Pakistan
  • Peru
  • Uganda

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 NCT02581527 on ClinicalTrials.gov