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

NCT04717908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

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 bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB .

Conditions

  • Multidrug Resistant Tuberculosis

Interventions

DRUG

Bedaquiline

400 mg once daily for 2 weeks then 200mg 3 times per week;

DRUG

Pyrazinamide

1500 mg daily

DRUG

Linezolid

600 mg daily

DRUG

Cycloserine

≤50kg 500 mg daily, \>50kg 750mg daily;

DRUG

Clofazimine

100 mg daily;

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Wenhong Zhang, PhD · Huashan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2024-06-22
Completion
2024-06-22

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 NCT04717908 on ClinicalTrials.gov