Clinical Trial: Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old. A Multi-center Comparative Randomized Double-blind and P
Brief Summary: To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs.
Detailed Summary:
Background: Bacterial meningitis has still a high morbi-mortality despite the global improvement in therapy.
Among complications, the presence of seizures may contribute to increase the morbi-mortality. Prophylactic phenytoin is used in clinical practice in high risk patients but this use is variable because there are not controlled clinical trials demonstrating efficacy along with antibiotics and corticosteorids. Pneumococcal episodes are associated to a higher number of seizures and a higher mortality especially in elderly patients.
Objectives: To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs.
Methodology: Multicentre, randomized, double blind placebo controlled clinical trial. Patients will be included mostly from hospitals from REIPI and CAIBER and randomly assigned to receive phenytoin or placebo.
Sample size has been estimated in 61 patients per group. Antibiotic therapy and ICP prophylaxis will be standardized in all centres. Phenytoin administration will be maintained during antibiotic therapy. End point will be incidence of seizures during hospital stay and overall mortality will be a secondary end-point. Followup visits at 1 and 3 month will be performed.
Sponsor: M. Carmen Cabellos Minguez
Current Primary Outcome: Presence of seizures (clinical) after initiation of phenytoin /placebo prophylaxis during the 10 days of antibiotic therapy [ Time Frame: 10 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Need for anticonvulsivant therapy at 3 months [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Hospital Universitari de Bellvitge
Dates:
Date Received: November 21, 2011
Date Started: November 2011
Date Completion: March 2014
Last Updated: December 19, 2012
Last Verified: December 2012
