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Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan

NCT02496572 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2015-07-14

No results posted yet for this study

Summary

Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in Uzbekistan shows that the current standard treatment greatly limits the ability to scale up to meet the high rates of MDR TB in the region.

Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a relapse-free cure rate of 88%. Several countries in West Africa started implementing similar regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among regions with high second line drug use and resistance is still limited.

The investigators propose an observational study under programmatic conditions to evaluate the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug resistant (XDR) TB prevalence and high second-line drug resistance setting of Karakalpakstan, Uzbekistan.

Conditions

  • Multidrug Resistant Tuberculosis

Interventions

DRUG

Short course MDR-TB treatment regimen

Intensive phase: Pyrazinamide (Z) + Ethambutol (E) + Isoniazid (H) + Moxifloxacin (Mfx) + Capreomycin (Cm) + Prothionamide (Pto) + Clofazimine (Cfz) for at least 4 months and until one negative culture is documented with a maximum of 6 months duration. Continuation phase: Continuation phase of Pyrazinamide (Z) + Ethambutol (E) + Moxifloxacin (Mfx) + Prothionamide (Pto) + Clofazimine (Cfz) for fixed 5 months duration.

Sponsors & Collaborators

  • Ministry of Health, Republic of Uzbekistan

    collaborator OTHER_GOV

  • Imperial College London

    collaborator OTHER

  • Medecins Sans Frontieres, Netherlands

    lead OTHER

Principal Investigators

  • Philipp du Cros, MBBS · Medecins sans Frontieres (MSF)

  • Khamraev A Karimovich, MD · Ministry of Health, Republic of Uzbekistan

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • Uzbekistan

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 NCT02496572 on ClinicalTrials.gov