Double blind placebo-controlled trial of pleconaril in infants with enterovirus meningitis
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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Several studies have shown that pleconaril shortens the course of symptoms, especially headache, but other studies have shown no significant difference between treatment and placebo groups.
“Several studies have shown that pleconaril plays an important role in shortening the course of symptoms, especially headache [6, 99]. However, other studies have shown that there was no significant difference between treatment and placebo groups [100].”
From Viral meningitis: an overview (2021) · cites this paper as [100]
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Viral Central Nervous System Infections
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Caboxamycin Inhibits Heart Inflammation in a Coxsackievirus B3-Induced Myocarditis Mouse Model
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Self-citationLumbar Puncture is Not Needed for All Patients Suspected to Have Viral Meningitis
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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)
- Venue
- The Pediatric Infectious Disease Journal
- Published
- 2003-04
- Volume
- 22
- Issue
- 4
- Pages
- 335-340
- ISSN
- 0891-3668 (ISSN-L)
- 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 › Cardiology and Cardiovascular Medicine › 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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