Which antibiotic is better to prevent meningitis after head injury: Ampicillin or Ceftriaxone?
Phase 3
- Conditions
- Health Condition 1: null- Adult (above 12 years) brain trauma patients who reach the hospital within 24 hours of trauma in whom CT scan is showing pneumocephalus (air bubbles inside the cranial cavity)Health Condition 2: G939- Disorder of brain, unspecified
- Registration Number
- CTRI/2013/07/003831
- Lead Sponsor
- Gopalakrishnan MS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All adult (above 12 years) brain trauma patients who reach the hospital within 24 hours of trauma in whom CT scan is showing pneumocephalus
Exclusion Criteria
1.Patient in whom the treating doctor feels that antibiotics are necessary for any other indication immediately or is very likely to require antibiotics in the next five days.
Example: A patient with compound depressed fracture who is being taken up for surgical debridement
2.Patient with a known severe penicillin allergy.
3.Patient with known severe renal failure..
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the proportion of patients with traumatic pneumocephalus who develop meningitis when ampicillin is used prophylactically compared to ceftriaxone.Timepoint: At any point during the five day period when trial drugs are being used and for a further duration of 48 hours. (total of seven days)
- Secondary Outcome Measures
Name Time Method ) If there is a correlation with the volume of pneumocephalus and the frequency of development of meningitis.Timepoint: Anytime within after start of intervention.;If there is an increased frequency of occurrence of meningitis by more virulent or drug resistant bacterial strain when ampicillin is used as the prophylactic drug compared to ceftriaxoneTimepoint: Total of seven days after start of intervention;the frequency of side effects which could be attributed to the drugsTimepoint: seven days after start of trial;To compare the mortality due to meningitis and all-cause mortality in both groups.Timepoint: Any in-hospital mortality within 30 days of admission is recorded.