Pediatric tuberculous meningitis: model-based approach to determining optimal doses of the anti-tuberculosis drugs rifampin and levofloxacin for children

Citation: Savic RM, Ruslami R, Hibma JE, Hesseling A, Ramachandran G, Ganiem AR, Swaminathan S, McIlleron H, Gupta A, Thakur K, van Crevel R, Aarnoutse R, Dooley KE. Pediatric tuberculous meningitis: model-based approach to determining optimal doses of the anti-tuberculosis drugs rifampin and levofloxacin for children. Clin Pharmacol Ther. 2015 Dec;98(6):622-9. doi: 10.1002/cpt.202. Epub 2015 Oct 22. PMID: 26260983. PMCID: PMC4888594.

Access full article:

http://www.ncbi.nlm.nih.gov/pubmed/26260983

Pediatric TB meningitis (TBM) is a highly-morbid, oft-fatal disease. Standard treatment includes isoniazid, rifampin, pyrazinamide, and ethambutol. Current rifampin dosing achieves low cerebrospinal fluid (CSF) concentrations, and CSF penetration of ethambutol is poor. In adult trials, higher-dose rifampin and/or a fluoroquinolone reduced mortality and disability. To estimate optimal dosing of rifampin and levofloxacin for children, we compiled plasma and CSF pharmacokinetic and outcomes data from adult TBM trials plus plasma pharmacokinetic data from children. A population pharmacokinetic/pharmacodynamic model using adult data defined rifampin target exposures (plasma AUC0-24 =92 mg*h/L). Levofloxacin targets and rifampin pediatric drug disposition information were literature-derived. To attain target rifampin exposures, children require daily doses of at least 30 mg/kg orally or 15 mg/kg intravenously. From our pediatric population PK model, oral levofloxacin doses needed to attain exposure targets were 19-33 mg/kg. Our results provide data-driven guidance to maximize pediatric TBM treatment while we await definitive trial results. This article is protected by copyright. All rights reserved.

Clin Pharmacol Ther. 2015 Aug 11. doi: 10.1002/cpt.202. [Epub ahead of print]. PMID: 26260983 [PubMed - as supplied by publisher]

Categories

CRS
Topics

Clinical Trials

A5290, A Randomized, Phase 2b Study of a Double-Dose...

Rifampin (RIF), the cornerstone of TB treatment, has very problematic drug-drug interactions with PIs. The use of relatively...

Read More

A5314: Effect of LDMTX on Inflammation in HIV-infected...

A5314 is a phase II randomized, double-blind, placebo-controlled 36-week trial that will examine the safety and efficacy of...

Read More

A5302:  BioBank for Surrogate Marker Research for TB...

Primary Objective To obtain sputum, serum, urine, and peripheral blood mononuclear cells (PBMCs) for central TB biorepository...

Read More

P2026: Pharmacokinetic Properties of Antiretroviral and...

IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women,...

Read More

A5273: Multicenter Study of Options for Second-Line...

The study is being done with people who are taking their first anti-HIV drug regimen (including an Non-Nucleoside Reverse...

Read More