A Phase 4 interventional study of Phenytoin and placebo in Seizures and Pneumococcal Meningitis, sponsored by M. Carmen Cabellos Minguez. Terminated at 4 sites in Spain. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by M. Carmen Cabellos Minguez · Phase 4, Interventional, and Prevention
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.
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.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 26 is below the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →This is the only study on the registry with M. Carmen Cabellos Minguez as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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 Criteria:
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.
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 vials and pills labeled as phenytoin prophylaxis vials and pills
Drug: placebo
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 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.
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
Time frame: 10 days
Need for anticonvulsivant therapy at 3 months
Need for anticonvulsivant therapy at 3 months
Time frame: 3 months
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Meningitis, Pneumococcal