Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.
Recruitment status was Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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 Placebo-controlled Clinical Trial|
- Presence of seizures (clinical) after initiation of phenytoin /placebo prophylaxis during the 10 days of antibiotic therapy [ Time Frame: 10 days ] [ Designated as safety issue: No ]Presence of seizures (clinical) after initiation of phenytoin /placebo prophylaxis during the 10 days of antibiotic therapy
- Need for anticonvulsivant therapy at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Need for anticonvulsivant therapy at 3 months
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: phenytoin prophylaxis
Patients with suspected or proven pneumococcal meningitis are allocated to receive phenytoin prophylaxis or placebo to avoid seizures during the 10 days of antibiotic therapy starting after the antibiotic therapy
Phenytoin 18 mg /Kg/day iv as loading dose. 24 hours later phenytoin 6 mg/Kg/d in 3 divided doses iv shifting to oral route at the same dose when the patient is able to use oral route.
Placebo Comparator: placebo
placebo vials and pills labeled as phenytoin prophylaxis vials and pills
Placebo 18 mg /Kg/day iv as loading dose. 24 hours later placebo 6 mg/Kg/d in 3 divided doses iv shifting to oral route at the same dose when the patient is able to use oral route.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478035
|Contact: M. Carmen Cabellos, MDfirstname.lastname@example.org|
|Hospital Universitari de Bellvitge||Recruiting|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Contact: Carmen Cabellos 34932607625 email@example.com|
|Principal Investigator: M. Carmen Cabellos, MD|
|Hospital Juan Canalejo||Recruiting|
|A Coruña, Spain, 15006|
|Contact: Efren Sanchez Efren.Sanchez.Vidal@sergas.es|
|Principal Investigator: Efren Sanchez|
|Fundacio Institut per la Recerca de l'hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: Virginia Pomar VPomar@santpau.cat|
|Principal Investigator: Virginia Pomar|
|Hospital Virgen del Rocio||Recruiting|
|Sevilla, Spain, 41013|
|Contact: Enrique Mejias MEJ-MEJIAS@telefonica.net|
|Principal Investigator: Enrique Mejias|
|Principal Investigator:||M. Carmen Cabellos, MD||Hospital Universitari de Bellvitge|