Optimizing Treatment to Improve TBM Outcomes in Children

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

November 15, 2020

Study Completion Date

November 15, 2020

Conditions
Tuberculosis, Meningeal
Interventions
DRUG

High-dose: RIF, INH, PZA, EMB

high-dose rifampicin plus standard dose H,Z,E, given for 8 weeks in treatment Arms 1 and 2

DRUG

High dose: RIF, INH, PZA, LEVO

high-dose rifampicin plus standard dose H,Z, with levofloxacin substituted for ethambutol for 8 weeks in treatment Arm 2

DRUG

Standard of care: RIF, INH, PZA, EMB

standard doses of R,H,Z,E given for 8 weeks in treatment Arm 3, control arm.

Trial Locations (3)

411001

Byramji Jeejeebhoy Government Medical College and Sassoon Hospital, Pune

600031

National Institute of Research in TB and Institute of Child Health, Chennai

Unknown

UNC Project- Malawi, Lilongwe

All Listed Sponsors
collaborator

National Institute for Research in Tuberculosis, Chennai, India

UNKNOWN

collaborator

University of North Carolina

OTHER

collaborator

B. J. Medical College, Pune

OTHER

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Johns Hopkins University

OTHER

NCT02958709 - Optimizing Treatment to Improve TBM Outcomes in Children | Biotech Hunter | Biotech Hunter