NCT01478035

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

3.3 years

First QC Date

November 21, 2011

Last Update Submit

February 28, 2023

Conditions

SeizuresPneumococcal Meningitis

Keywords

Phenytoin prophylaxisPneumococcal meningitisRandomizedPlacebo-controlledDouble blindPatient 50 years or older

Outcome Measures

Primary Outcomes (1)

  • Presence of seizures (clinical) after initiation of phenytoin /placebo prophylaxis during the 10 days of antibiotic therapy

    Presence of seizures (clinical) after initiation of phenytoin /placebo prophylaxis during the 10 days of antibiotic therapy

    10 days

Secondary Outcomes (1)

  • Need for anticonvulsivant therapy at 3 months

    3 months

Study Arms (2)

phenytoin prophylaxis

EXPERIMENTAL

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

Drug: Phenytoin

placebo

PLACEBO COMPARATOR

placebo vials and pills labeled as phenytoin prophylaxis vials and pills

Drug: placebo

Interventions

PhenytoinDRUG

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.

phenytoin prophylaxis
placeboDRUG

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.

placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \> or = 50 years old.
  • Diagnosed of pneumococcal meningitis due to clinical characteristics plus a positive CSF Gram stain and/or a detection of pneumococcal antigen or PCR
  • Suspected pneumococcal meningitis since it is an episode related to otitis, pneumonia, sinusitis or pericranial fistula or in patients with known risk factors such as myeloma or splenectomy.

You may not qualify if:

  • Pregnancy or breastfeeding.
  • To have conduction abnormalities in ECG.
  • History of allergy or intolerance to phenytoin.
  • Patients with meningitis as a complication of neurosurgical procedures.
  • Epileptic patients taking usually anticonvulsivants.
  • Refusal by the patient or family to participate and/or to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Juan Canalejo

A Coruña, 15006, Spain

Location

Fundacio Institut per la Recerca de l'hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Conditions

SeizuresMeningitis, Pneumococcal

Interventions

Phenytoin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMeningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumococcal InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesMeningitisNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • M. Carmen Cabellos, MD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations

ES(4)