MedTrace Logo

Pilot Clinical Trial of PRS TB Regimen I - Phase II

NCT03561753 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2020-11-09

No results posted yet for this study

Summary

Tuberculosis is the current leading cause of death due to an identifiable infectious agent worldwide. The current standard regimen for tuberculosis requires a patient to take drug combination (isoniazid, rifampicin, ethambutol, and pyrazinamide) for six to eight month periods. The purpose of this study is to compare tuberculosis treatment therapy between the current standard regimen and PRS derived combinatorial regimen. PRS derived regimen may potentially allow for a shorter course of treatment, which may reduce problems associated with adherence, toxicity, and development of drug resistance.

Conditions

  • Pulmonary Tuberculosis TB in Sputum: (+) Microscopy

Interventions

DRUG

Group A (the standard 2HRZE/4HR regimen）

The standard six-month regimen is eight weeks of daily treatment with isoniazid, rifampin, ethambutol, and pyrazinamide followed by sixteen weeks of isoniazid and rifampin. The six-month regimen is the standard regimen for the treatment of drug-susceptible tuberculosis recommended by WHO.

DRUG

Group B (New short course PRS regimen, 4EZ(high dose)PtoCfz)

The PRS regimen I（new short course PRS regimen） is 4 months of daily Cfz, Emb, Pto, and high dose pyrazinamide, dosed by weight.Comparison of Standard Regimen：The standard six-month regimen is eight weeks of daily treatment with isoniazid, rifampin, ethambutol, and pyrazinamide followed by sixteen weeks of isoniazid and rifampin.

Sponsors & Collaborators

  • Shanghai Center for Disease Control and Prevention

    collaborator OTHER

  • No.85 Hospital, Changning, Shanghai, China

    collaborator OTHER

  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of California, Los Angeles

    collaborator OTHER

  • 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
2017-12-01
Primary Completion
2019-12-31
Completion
2020-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT03561753 on ClinicalTrials.gov