Prophylactic antibiotics for the prevention of meningitis after traumatic pneumocephalus
| ISRCTN | ISRCTN71132784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71132784 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/03/2005
- Registration date
- 11/03/2005
- Last edited
- 20/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Behzad Eftekhar
Scientific
Scientific
Dept of Neurosurgery
Sina Hospital
Imam Ave
Tehran
15116
Iran
| eftekhar@sina.tums.ac.ir |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prophylactic antibiotics for the prevention of meningitis after traumatic pneumocephalus: a randomised controlled trial |
| Study objectives | 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(s) | This study has been ethically approved by Sina Trauma and Surgery Research Center, Tehran University. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 186 |
| Key inclusion criteria | 1. Traumatic pneumocephalus verified by brain computed tomography (CT) scan 2. The patients should be hospitalised less than 24 hours after trauma |
| Key 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 |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Iran
Study participating centre
Dept of Neurosurgery
Tehran
15116
Iran
15116
Iran
Sponsor information
Tehran University of Medical Sciences (TUMS) (Iran)
Hospital/treatment centre
Hospital/treatment centre
Sina Trauma and Surgery Research Center
Sina Hospital
Imam Ave
Tehran
11365/3876
Iran
| sintrc_head@sina.tums.ac.ir | |
"ROR" |
https://ror.org/01c4pz451 |
Funders
Funder type
Hospital/treatment centre
Sina Trauma and Surgery Research Center (Iran)
No information available
Tehran University of Medical Sciences (Iran)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/01/2006 | Yes | No |
Editorial Notes
20/09/2017: internal review.
