Evaluation of efficacy of prophylactic antibiotic therapy in prevention of incidence of meningitis in patient with basilar skull fracture and cerebrospinal fluid leakage

Evaluation of efficacy of prophylactic antibiotic therapy in prevention of incidence of meningitis in patient with basilar skull fracture and cerebrospinal fluid leakage in traumatic patient reffer to golestan hospital of ahvaz in 2014-2015

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014123020485N1

Enrollment

346

Registered

2015-05-25

Start date

2015-02-08

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Fracture of base of skull due to trauma. Fracture of base of skull

Interventions

Intervention 1: Approximately 178 patients with CSF leak following base skull fractures were selected. For prophylaxis, two Cotrimoxazole tablets (400/80 miligram) and three Amoxicillin capsules (500

Prevention

Approximately 178 patients with CSF leak following base skull fractures were selected. For prophylaxis, two Cotrimoxazole tablets (400/80 miligram) and three Amoxicillin capsules (500 miligram) were a

In the control group, placebo drugs with complete resemblance to the actual drugs were given to patients (two Cotrimoxazole placebo tablets and three Amoxicillin placebo capsules, daily). The placebo

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (Inclusion criteria:Selected patients suffered from traumatic base skull fractures with cerebrospinal fluid leakage characterized by rhinorrhea or otorrhea;All participants were at least 18 years old) (Exclusion criteria: Patients with visible lesions on CT scans in need of surgery;patient with Depressed skull fracture, space-occupying lesions, signs of intracranial pressure increase;patients with cerebrospinal fluid disturbance and/ or meningitis; In cases with signs of meningitis such as fever, purulent discharge, meningismus)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Prevention of incidence of meningitis in patient with basilar skull fracture and csf leakage. Timepoint: TBI patient reffer to Golestan hospital of ahvaz in 2014-2015. Method of measurement: Analyse of csf obtain frome lumbar puncture.	—

Secondary

Measure	Time frame
Incidence of meningitis. Timepoint: in course of admision. Method of measurement: with lumbar puncture and analyse of cerebrospinal fuid sample.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hasan Akbardokht

Ahvaz Jundishapour Medical Sciences University

akbardokht@yahoo.com+98 61 3374 3032

Outcome results

None listed

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