Condition category
Injury, Occupational Diseases, Poisoning
Date applied
02/03/2005
Date assigned
11/03/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

Not Specified

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

Results - basic reporting

Publication summary

Design and rationale of trial in http://www.ncbi.nlm.nih.gov/pubmed/16542035

Publication citations

  1. 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.

Additional files

Editorial Notes