Optimizing Treatment to Improve TBM Outcomes in Children
Status:
Completed
Trial end date:
2020-11-15
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
B. J. Medical College, Pune Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute for Research in Tuberculosis, Chennai, India University of North Carolina