Pilot Clinical Trial of PRS TB Regimen I - Phase II

PHASE4CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

December 1, 2017

Primary Completion Date

December 31, 2019

Study Completion Date

January 31, 2020

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.

Trial Locations (4)

200000

Eighty-fifth Hospital of PLA, Shanghai

Shanghai Public Health Clinical Center Shanghai, China, Shanghai

200336

Shanghai Center for Disease Control and Prevention, Shanghai

200433

Shanghai Pulmonary Hospital, Shanghai, China, Shanghai

All Listed Sponsors
collaborator

Shanghai Center for Disease Control and Prevention

OTHER

collaborator

No.85 Hospital, Changning, Shanghai, China

OTHER

collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

University of California, Los Angeles

OTHER

lead

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

NCT03561753 - Pilot Clinical Trial of PRS TB Regimen I - Phase II | Biotech Hunter | Biotech Hunter