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Novel Triple-dose Tuberculosis Retreatment Regimen

NCT04260477 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2025-04-13

No results posted yet for this study

Summary

To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).

Conditions

  • Multidrug-resistant Tuberculosis
  • Pulmonary Tuberculosis
  • Tuberculosis
  • Resistance to Tuberculostatic Drugs

Interventions

DRUG

6EH³R³Z

A triple dose is defined as the triple of the routine dose used for a specific WHO weight band. Hence, the mg/kg within a weigh-band varies, as is the case in routine practice. Dosing takings into consideration the fixed dose combination (FDC) tablets (one tablet: 150 mg R + 75 mg H + 400 mg Z + 275mg E). Dosage relies on tables with dosage by weight-bands used by WHO for the Cat. 1 regimen. The dosage used for the intensive phase of the Cat. 1 regimen applies for the whole treatment duration. A double dose of H and R is added to the recommended normal dose for adults (WHO,2003)

DRUG

6EHRZ

Recommended normal dose adults (WHO, 2003) * H: 5 (4-6) mg/kg/day * R: 10 (8-12) mg/kg/day * Z: 25 (20-30)mg/kg/day * E: 15 (15-18)mg/kg/day

Sponsors & Collaborators

  • Damien Foundation

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Sani Kadri · Ministry of Health, Niger

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2025-06-30
Completion
2025-09-30

Countries

  • Niger

Study Locations

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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 NCT04260477 on ClinicalTrials.gov