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Prophylactic antibiotics for the prevention of meningitis after traumatic pneumocephalus

Prophylactic antibiotics for the prevention of meningitis after traumatic pneumocephalus: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71132784
Enrollment
186
Registered
2005-03-11
Start date
2004-12-01
Completion date
Unknown
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic pneumocephalus (entrance of air into the cranium after head trauma) Injury, Occupational Diseases, Poisoning Traumatic pneumocephalus

Interventions

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

Sponsors

Tehran University of Medical Sciences (TUMS) (Iran)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Traumatic pneumocephalus verified by brain computed tomography (CT) scan 2. The patients should be hospitalised less than 24 hours after trauma

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The frequency of bacterial meningitis in IV, O and P groups.

Secondary

MeasureTime frame
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

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026