Study of the efficacy of phenytoin in the prophylaxis of seizures in patients with pneumococcal meningitis aged 50 years or older. Comparative, multicenter, placebo-controlled, double-blind, randomized clinical trial

INTERVENTION: Trade Name: Fenitoína G.E.S 50mg/ ml solución inyectable Pharmaceutical Form: Solution for injection INN or Proposed INN: FENITOINA SODICA CAS Number: 630‐93‐3 Other descriptive name: FENITOINA SODICA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: SINERGINA 100 mg Comprimidos Pharmaceutical Form: Tablet INN or Proposed INN: FENITOINA CAS Number: 57‐41‐0 Other descriptive name: PHENYTOIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Seizure prophylaxis in pneumococcal meningitis; MedDRA version: 13 Level: LLT Classification code 10027253 Term: Pneumococcal meningitis PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of phenytoin prophylaxis versus placebo in the prevention of seizures in patients with pneumococcal meningitis aged 50 years or older. Primary endpoint(s): Presence of seizures (clinical) after the start of prophylaxis with phenytoin/placebo during the 10 days of antibiotic treatment. To define the presence of seizures, the criteria of the "International Classification of Seizures" and the "International Classification of Epilepsies and Epilepsy syndromes", accepted by the EMA for clinical trials with Antiepileptic drugs Secondary Objective: To evaluate the efficacy of phenytoin prophylaxis vs placebo in improving the prognosis in terms of mortality in patients with pneumococcal meningitis aged 50 years or older; To determine the incidence of seizures as a sequela and the need for anticonvulsant treatment at 3 months; To identify electroencephalographic abnormalities without clinical manifestations during the patient's admission; To determine the incidence and severity of adverse reactions during the course of phenytoin treatment INCLUSION CRITERIA: Adult patients aged 50 years or older diagnosed with bacterial meningitis based on clinical and CSF characteristics who: 1) are initially classified as having pneumococcal etiology based on the results of CSF Gram staining and/or detection of pneumococcal antigen in CSF; or (2) they are classified as suspected pneumococcal etiology because it is an episode associated with otitis, sinusitis, pneumonia, CSF fistula or known risk factors (myeloma, splenectomy, etc.). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range