Optimizing Treatment to Improve TBM Outcomes in Children (TBM-KIDS)

NCT02958709 PHASE1, PHASE2 COMPLETED

In this open-labeled, randomized clinical trial, the Investigator will assess the safety and pharmacokinetics (PK) of model-optimized doses of rifampicin (RIF) with or without levofloxacin (LEVO) given to children as part of multidrug treatment for tuberculous meningitis (TBM) versus standard treatment. The Investigators will also assess functional and neurocognitive outcomes by treatment group, as measured by the Pediatric Modified Rankin Score (MRS) and the Mullen Scales of Early Learning (MSEL), respectively.

Details

Lead sponsor	Johns Hopkins University
Phase	PHASE1, PHASE2
Status	COMPLETED
Enrolment	38
Start date	Wed Feb 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sun Nov 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Tuberculosis, Meningeal

Interventions

• High-dose: RIF, INH, PZA, EMB
• High dose: RIF, INH, PZA, LEVO
• Standard of care: RIF, INH, PZA, EMB

Countries

Malawi, India