Optimizing Treatment to Improve TBM Outcomes in Children

Phase 1/2 Completed 38 enrolled Johns Hopkins University B. J. Medical College, Pune · collab Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab National Institute for Research in Tuberculosis, Chennai, India · collab University of North Carolina · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-02-22
Primary completion: 2020-11-15
Completion: 2020-11-15

Publications

Paradkar MS, Devaleenal D B, Mvalo T, Arenivas A, Thakur KT, Wolf L, Nimkar S, Inamdar S, Giridharan P, Selladurai E, Kinikar A, Valvi C, Khwaja S, Gadama D, Balaji S, Yadav Kattagoni K, Venkatesan M, Savic R, Swaminathan S, Gupta A, Gupte N, Mave V, Dooley KE; TuBerculous Meningitis in Kids (TBM-KIDS) Study Team. Randomized Clinical Trial of High-Dose Rifampicin With or Without Levofloxacin Versus Standard of Care for Pediatric Tuberculous Meningitis: The TBM-KIDS Trial. Clin Infect Dis. 2022 Oct 29;75(9):1594-1601. doi: 10.1093/cid/ciac208.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ethambutol	Small molecule	—	—
Subject	Levofloxacin	Small molecule	—	—
Subject	Rifampicin	Small molecule	15 mg/kg	—
Subject	Rifampicin	Small molecule	30 mg/kg	—
Background	Isoniazid	Small molecule	—	—
Background	Pyrazinamide	Small molecule	—	—

Optimizing Treatment to Improve TBM Outcomes in Children

Summary

Timeline

Publications

Drugs

Indications