Which antibiotic is better to prevent meningitis after head injury: Ampicillin or Ceftriaxone?

Randomised controlled trial of the efficacy of ampicillin versus ceftriaxone for prevention of meningitis in traumatic pneumocephalus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003831

Enrollment

192

Registered

2013-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

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

Interventions

Intervention1: Ampicillin: Intravenous injection of Ampicillin 1 gram every fourth hourly for five days Control Intervention1: Ceftriaxone: Intravenous injection of Ceftriaxone 1 gram every 12 hours

Eligibility

Inclusion criteria

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

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. .

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
) 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.	—

Measure

Time frame

) 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.

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Countries

India

Contacts

Public ContactGopalakrishnan MS

Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)

gopalakrishnanms@gmail.com919345141431

Outcome results

None listed

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