Contact information
Type
Scientific
Primary contact
Dr Behzad Eftekhar
ORCID ID
Contact details
Dept of Neurosurgery
Sina Hospital
Imam Ave
Tehran
15116
Iran
-
eftekhar@sina.tums.ac.ir
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prophylactic antibiotics for the prevention of meningitis after traumatic pneumocephalus: a randomised controlled trial
Acronym
Study hypothesis
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.
Ethics approval
This study has been ethically approved by Sina Trauma and Surgery Research Center, Tehran University.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Traumatic pneumocephalus (entrance of air into the cranium after head trauma)
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Ceftriaxone, azithromycin
Primary outcome measure
The frequency of bacterial meningitis in IV, O and P groups.
Secondary outcome measures
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
Overall trial start date
01/12/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Traumatic pneumocephalus verified by brain computed tomography (CT) scan
2. The patients should be hospitalised less than 24 hours after trauma
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
186
Participant exclusion criteria
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
Recruitment start date
01/12/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Iran
Trial participating centre
Dept of Neurosurgery
Tehran
15116
Iran
Sponsor information
Organisation
Tehran University of Medical Sciences (TUMS) (Iran)
Sponsor details
Sina Trauma and Surgery Research Center
Sina Hospital
Imam Ave
Tehran
11365/3876
Iran
-
sintrc_head@sina.tums.ac.ir
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sina Trauma and Surgery Research Center (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Tehran University of Medical Sciences (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 protocol in https://www.ncbi.nlm.nih.gov/pubmed/16542035
Publication citations
-
Design and rationale of trial
Eftekhar B, Ghodsi M, Hadadi A, Taghipoor M, Sigarchi SZ, Rahimi-Movaghar V, Kazemzadeh ES, Esmaeeli B, Nejat F, Yalda A, Ketabchi E, Prophylactic antibiotic for prevention of posttraumatic meningitis after traumatic pneumocephalus: design and rationale of a placebo-controlled randomized multicenter trial [ISRCTN71132784]., Trials, 2006, 7, 2, doi: 10.1186/1745-6215-7-2.