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Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)

NCT03867136 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2024-11-12

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks (regimen consisted of clofazimine for 36\~44 weeks) in subjects with multidrug-resistant tuberculosis (MDR-TB) compared to WHO standardized shorter regimen of 36-44 weeks.

Conditions

  • Multidrug Resistant Tuberculosis

Interventions

DRUG

PZA sensitivity guided ultra-short all Oral Regimen

Pyrazinamide 1500 mg daily; Levofloxacin ≤50kg 500 mg daily, \>50kg 750mg daily; Linezolid: 600 mg daily; Cycloserine ≤50kg 500 mg daily, \>50kg 750mg daily; Clofazimine 100 mg daily; All treatment is taken daily;

DRUG

Standardized Shorter Regimen

Pyrazinamide 1500 mg daily;Levofloxacin 400 mg daily,; Prothionamide ≤50kg 500 mg daily, \>50kg 750mg daily; Ethambutol: ≤50kg 750 mg daily, \>50kg 1000mg daily; Clofazimine: 100 mg daily; Amikacin 600mg daily; High-dose isoniazid 600mg daily. All treatment is taken daily.

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Wenhong Zhang, PhD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2024-08-10
Completion
2024-08-10

Countries

  • China

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 NCT03867136 on ClinicalTrials.gov