Status:
TERMINATED
Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.
Lead Sponsor:
M. Carmen Cabellos Minguez
Collaborating Sponsors:
Hospital Universitari de Bellvitge
Hospital Vall d'Hebron
Conditions:
Seizures
Pneumococcal Meningitis
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 ...
Detailed Description
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-mortali...
Eligibility Criteria
Inclusion
- 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
- or
- 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.
Exclusion
- To have seizures prior to arrive to the hospital or the inclusion in the study.
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01478035
Start Date
November 1 2011
End Date
December 1 2015
Last Update
March 2 2023
Active Locations (4)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
Hospital Juan Canalejo
A Coruña, Spain, 15006
3
Fundacio Institut per la Recerca de l'hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
4
Hospital Virgen del Rocio
Seville, Spain, 41013