Pleconaril provided sufficient plasma levels but showed drug accumulation, with no significant differences in viral positivity, hospitalization, or symptoms compared to placebo.
RCT (n=21)
Double-blind
2:1
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 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.
Abzug et al. (Tue,) conducted a rct in Enterovirus meningitis (n=21). Pleconaril vs. Placebo was evaluated on Pharmacokinetics, safety, and efficacy (duration of positivity by culture or PCR, hospitalization, or symptoms). Pleconaril provided sufficient plasma levels but showed drug accumulation, with no significant differences in viral positivity, hospitalization, or symptoms compared to placebo.