Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Seizures Pneumococcal Meningitis |
Drug: Phenytoin Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old. A Multi-center Comparative Randomized Double-blind and Placebo-controlled Clinical Trial |
- Presence of seizures (clinical) after initiation of phenytoin /placebo prophylaxis during the 10 days of antibiotic therapy [ Time Frame: 10 days ] [ Designated as safety issue: No ]Presence of seizures (clinical) after initiation of phenytoin /placebo prophylaxis during the 10 days of antibiotic therapy
- Need for anticonvulsivant therapy at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Need for anticonvulsivant therapy at 3 months
| Estimated Enrollment: | 122 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: phenytoin prophylaxis
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
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 Comparator: placebo
placebo vials and pills labeled as phenytoin prophylaxis vials and pills
|
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.
|
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-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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Contacts and Locations| Contact: M. Carmen Cabellos, MD | +34932607625 | ccabellos@bellvitgehospital.cat |
| Spain | |
| Hospital Universitari de Bellvitge | Recruiting |
| L'Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Contact: Carmen Cabellos 34932607625 ccabellos@bellvitgehospital.cat | |
| Principal Investigator: M. Carmen Cabellos, MD | |
| Hospital Juan Canalejo | Recruiting |
| A Coruña, Spain, 15006 | |
| Contact: Efren Sanchez Efren.Sanchez.Vidal@sergas.es | |
| Principal Investigator: Efren Sanchez | |
| Fundacio Institut per la Recerca de l'hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Virginia Pomar VPomar@santpau.cat | |
| Principal Investigator: Virginia Pomar | |
| Hospital Virgen del Rocio | Recruiting |
| Sevilla, Spain, 41013 | |
| Contact: Enrique Mejias MEJ-MEJIAS@telefonica.net | |
| Principal Investigator: Enrique Mejias | |
| Principal Investigator: | M. Carmen Cabellos, MD | Hospital Universitari de Bellvitge |
More Information
No publications provided
| Responsible Party: | M. Carmen Cabellos Minguez, Medical Doctor, Hospital Universitari de Bellvitge |
| ClinicalTrials.gov Identifier: | NCT01478035 History of Changes |
| Other Study ID Numbers: | INFSNC1 |
| Study First Received: | November 21, 2011 |
| Last Updated: | December 19, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Hospital Universitari de Bellvitge:
|
Phenytoin prophylaxis Pneumococcal meningitis Randomized |
Placebo-controlled Double blind Patient 50 years or older |
Additional relevant MeSH terms:
|
Meningitis Meningitis, Pneumococcal Meningitis, Bacterial Seizures Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Central Nervous System Bacterial Infections Bacterial Infections Pneumococcal Infections Streptococcal Infections |
Gram-Positive Bacterial Infections Epilepsy Brain Diseases Neurologic Manifestations Signs and Symptoms Phenytoin Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013