Study protocol
Prophylactic antibiotic for prevention of posttraumatic meningitis after traumatic pneumocephalus: design and rationale of a placebo-controlled randomized multicenter trial [ISRCTN71132784]
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* Corresponding author: Behzad Eftekhar eftekhar@sina.tums.ac.ir
1 Sina Trauma and Surgery Research Center and Department of Neurosurgery, Sina Hospital, Tehran University, Iran
2 Department of Infectious Diseases, Sina Hospital, Tehran University, Iran
3 Department of Neurosurgery, Namazi Hospital, Shiraz University, Iran
4 Department of Neurosurgery, Ghaem Hospital, Mashad University, Iran
5 Department of Neurosurgery, Khatam-ol-anbia Hospital, Zahedan University, Iran
6 Department of Infectious Diseases, Imam Hospital, Tehran University, Iran
7 Department of Neurosurgery, Hospital, Shahrood, Iran
8 Department of Neurosurgery, Children's Hospital Medical Center, Tehran University, Iran
Trials 2006, 7:2 doi:10.1186/1745-6215-7-2
Published: 18 January 2006Abstract
Background
The purpose of this study is to compare the efficacy of prophylactic antibiotic for prevention of meningitis in acute traumatic pneumocephalus patients.
Methods
In this prospective, randomized controlled clinical trial, 200 selected head injury patients with traumatic pneumocephalus are randomly assigned to receive intravenous antibiotics (2 grams Ceftriaxone twice a day), oral antibiotics (Azithromycin) or placebo for at least 7 days after trauma. The patients will be followed for one month posttrauma.
Conclusion
The authors hope that this study helps clarifying the effectiveness and indications of antibiotics in prevention of meningitis in traumatic pneumocephalus after head injury and in specific subgroup of these patients.