Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.

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.

Conditions

• Seizures
• Pneumococcal Meningitis

Interventions

DRUG

Phenytoin

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.

DRUG

placebo

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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  collaborator OTHER

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Juan Canalejo

  collaborator OTHER

• Hospital Mutua de Terrassa

  collaborator OTHER

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• M. Carmen Cabellos Minguez

  lead OTHER

Principal Investigators

• M. Carmen Cabellos, MD · Hospital Universitari de Bellvitge

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2015-03-31

Completion

2015-12-31

Countries

• Spain

Study Locations