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A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB

NCT05278988 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-03

No results posted yet for this study

Summary

This is an exploratory, prospective, randomized, active control, and open label clinical trial to evaluate the efficacy and safety of 6-9 months treatment with the ultrashort PRS Regimen V.

Conditions

  • MDR-TB

Interventions

DRUG

PRS Regimen V

PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)

DRUG

MDR-TB Treatment Regimen(WHO)

Treatment according to WHO MDR-TB treatment guidelines (2019)

Sponsors & Collaborators

  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV

  • No.85 Hospital, Changning, Shanghai, China

    collaborator OTHER

  • Ganzhou Fifth People's Hospital, China

    collaborator UNKNOWN

  • Weifang Second People's Hospital, China

    collaborator UNKNOWN

  • Anhui Chest Hospital

    collaborator OTHER

  • Fourth Taiyuan People's Hospital, China

    collaborator UNKNOWN

  • Shanghai Pudong New Area Pulmonary Hospital, China

    collaborator UNKNOWN

  • Huashan Hospital

    collaborator OTHER

  • Zhengzhou Sixth People's Hospital, China

    collaborator UNKNOWN

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Principal Investigators

  • Sha wei · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2024-10-30
Completion
2024-10-30

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 NCT05278988 on ClinicalTrials.gov