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ISRCTN
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ISRCTN71132784
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ClinicalTrials.gov identifier
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Public title
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Prophylactic antibiotics for the prevention of meningitis after traumatic pneumocephalus
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Chemoprophylaxis with antibiotics is both feasible and desirable for prevention of a potentially serious disease when specific groups at risk can be defined and when a safe, effective, and affordable prophylactic agent is available. One of such potentially serious diseases is post-traumatic meningitis. The incidence of post-traumatic meningitis after head trauma ranges from 0.2 to 17.8 per cent and increases significantly in the presence of skull base fracture, pneumocephalus or cerebrospinal fluid (CSF) leak.
Considering the serious complications of the post-traumatic meningitis, the idea of chemoprophylaxis with antibiotics for prevention of post-traumatic meningitis has always been considered rational, but the efficacy of prophylactic antibiotic agents in the setting of post-traumatic CSF leakage is still controversial.
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Lay summary
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Ethics approval
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This study has been ethically approved by Sina Trauma and Surgery Research Center, Tehran University.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Iran
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Disease/condition/study domain
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Traumatic pneumocephalus (entrance of air into the cranium after head trauma)
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Participants - inclusion criteria
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1. Traumatic pneumocephalus verified by brain computed tomography (CT) scan
2. The patients should be hospitalised less than 24 hours after trauma
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Participants - exclusion criteria
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1. Patients who have received antibiotic therapy for other reasons
2. Individuals with penetrating traumatic brain injury, open skull fractures or operated for any causes
3. Those who are discharged from hospital with personal consent
4. All cases with life threatening lesions including severe brain, abdominal or vascular injuries and death due to other causes
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Anticipated start date
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01/12/2004
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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186
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Interventions
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The patients are divided into three groups:
1. Intravenous antibiotics (IV)
2. Oral antibiotics (O)
3. Placebo (P)
In the IV group, ceftriaxone 2 g twice daily (BID) plus oral placebo will be given and in the O group, azithromycin 500 mg in the first day followed by 250 mg daily plus intravenous placebo for the rest will be continued for 7 days. Antibiotics should be started in less than 24 hours after trauma.
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Primary outcome measure(s)
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The frequency of bacterial meningitis in IV, O and P groups.
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Secondary outcome measure(s)
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1. The frequency of rhinorrhoea, intracranial haemorrhage and skull base fracture, volume and location of intracranial air in the population study and each of the IV, O and P groups.
2. The mortality rate in study population and each of the IV, O and P groups
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Sources of funding
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1. Sina Trauma and Surgery Research Center (Iran)
2. Tehran University of Medical Sciences (Iran)
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Trial website
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Publications
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Design and rationale of trial in http://www.ncbi.nlm.nih.gov/pubmed/16542035
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Contact name
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Dr
Behzad
Eftekhar
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Address
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Dept of Neurosurgery
Sina Hospital
Imam Ave
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City/town
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Tehran
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Zip/Postcode
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15116
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Country
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Iran
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Email
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eftekhar@sina.tums.ac.ir
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Sponsor
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Tehran University of Medical Sciences (TUMS) (Iran)
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Address
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Sina Trauma and Surgery Research Center
Sina Hospital
Imam Ave
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City/town
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Tehran
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Zip/Postcode
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11365/3876
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Country
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Iran
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Email
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sintrc_head@sina.tums.ac.ir
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Date applied
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02/03/2005
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Last edited
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18/02/2008
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Date ISRCTN assigned
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11/03/2005
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