Cited by 138Viral Infections and Immunology ResearchInfectious Encephalopathies and EncephalitisLiterature Analysis and Criticism

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Double blind placebo-controlled trial of pleconaril in infants with enterovirus meningitis

ABZUG, MARK J., CLOUD, GRETCHEN, BRADLEY, JOHN, SÁNCHEZ, PABLO J., ROMERO, JOSÉ, POWELL, DWIGHT, LEPOW, MARTHA, MANI, CHITRA, CAPPARELLI, EDMUND V., BLOUNT, SHARON, LAKEMAN, FRED, WHITLEY, RICHARD J., KIMBERLIN, DAVID W.·2003·The Pediatric Infectious Disease Journal

DOI 10.1097/01.inf.0000059765.92623.70

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Abstract

Background Enterovirus (EV) meningitis is common in infants and may have neurologic complications. Treatment of older children and adults with pleconaril has been associated with reduced severity and duration of symptoms. This study evaluated the pharmacokinetics, safety and efficacy of pleconaril in infants with EV meningitis. Methods Infants Results Of 21 evaluable subjects 20 were confirmed with EV infection (12 pleconaril, 8 placebo). Among pleconaril-treated subjects 26 of 29 peak and trough pleconaril levels exceeded the 90% inhibitory concentration for EVs. A median 3.5-fold drug accumulation occurred between Days 2 and 7. Pleconaril was well-tolerated, although twice as many adverse events occurred per subject in the pleconaril group. Serial cultures from the oropharynx, rectum and serum had low yield ( or =50%) persisting through Day 14. No significant differences in duration of positivity by culture or PCR, hospitalization or symptoms were detected between groups. Conclusions The dose of pleconaril studied provided sufficient plasma levels and was well-tolerated; however, drug accumulation was evident. The low yields of serial viral cultures, relatively short and benign clinical courses and the small number of subjects enrolled precluded demonstration of efficacy. If this medication is to be prescribed in infants, surveillance for toxicity related to drug accumulation will be necessary.

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Authors: ABZUG, M. J., CLOUD, G., BRADLEY, J., SÁNCHEZ, P. J., ROMERO, J., POWELL, D., LEPOW, M., MANI, C., CAPPARELLI, E. V., BLOUNT, S., LAKEMAN, F., WHITLEY, R. J., & KIMBERLIN, D. W.
Affiliations: University of Colorado Anschutz (US)
ORCID: BRADLEY, JOHN
SÁNCHEZ, PABLO J.
CAPPARELLI, EDMUND V.
WHITLEY, RICHARD J.
KIMBERLIN, DAVID W.
Venue: The Pediatric Infectious Disease Journal
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2003-04
Volume: 22
Issue: 4
Pages: 335-340
ISSN: 0891-3668 (ISSN-L)
DOI: 10.1097/01.inf.0000059765.92623.70
OpenAlex: W2054734620
Cited by: 138
References: 15
Citations by year: 2026: 1 · 2025: 7 · 2024: 5 · 2023: 6 · 2022: 4 · 2021: 6 · 2020: 2 · 2019: 6 · 2018: 5 · 2017: 7 · 2016: 10 · 2015: 13 · 2014: 11 · 2013: 4 · 2012: 5
FWCI: 4.18
Type: journal article
Language: en
Open access: closed
Locations: The Pediatric Infectious Disease Journal (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (n01ai062554-008, n01ai015113-000)
National Institute of Allergy and Infectious Diseases (N01-AI -15113, N01 AI 62554)
Topics: Health Sciences › Medicine › Infectious Diseases › Viral Infections and Immunology Research
Health Sciences › Medicine › Infectious Diseases › Infectious Encephalopathies and Encephalitis
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Literature Analysis and Criticism
Keywords: pleconaril, enterovirus meningitis, infants, pharmacokinetics, drug accumulation, antiviral therapy, PCR detection, drug safety, adverse events, neurological complications
MeSH terms: Administration, Oral, Biological Availability, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Enterovirus Infections, Female, Follow-Up Studies, Humans, Infant, Male, Meningitis, Viral, Oxadiazoles, Oxazoles, Probability, Reference Values, Severity of Illness Index, Treatment Outcome, Risk Assessment

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Double blind placebo-controlled trial of pleconaril in infants with enterovirus meningitis

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