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Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More

NCT03862248 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-01-21

No results posted yet for this study

Summary

Drug-resistance is a major challenge for tuberculosis (TB) care programs. The new WHO guideline recommends adding levofloxacin in previously treated patients with isoniazid-resistant rifampicin-susceptible TB. The investigators believe that such a retreatment regimen may result in acquired resistance to fluoroquinolone, the core drug of multidrug-resistant TB (MDR-TB) regimen, and thus threaten the effectiveness of the fluoroquinolone-based MDR-TB treatment regimen. Therefore the investigators propose to study if regimens strengthened by using high-dose first-line drugs, either a triple dose of isoniazid or a triple dose of rifampicin, are non-inferior to the WHO recommended levofloxacin-strengthened regimen. If one of both high-dose regimens would be non-inferior, it could replace the levofloxacin-strengthened regimen.

Conditions

  • Tuberculosis, Pulmonary

Interventions

DRUG

6EH³RZ

New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg

DRUG

6EHR³Z

New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg

DRUG

6EHRZLfx

WHO levofloxacin-strengthened regimen (6EHRZLfx)

Sponsors & Collaborators

  • Damien Foundation

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Tom Decroo, MD · Insitute of Tropical Medicine Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • Bangladesh

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 NCT03862248 on ClinicalTrials.gov