Protocol summary

Summary
Patients with traumatic base skull fractures with cerebrospinal fluid leakage were selected. All participants underwent CT scans upon arrival. Patients with visible lesions on CT scans in need of surgery for example Depress skull fracture, space occupying lesions, signs of intracranial pressure increase excluded. At least 350 patient selected. Then placebo drugs with complete resemblance to cotrimoxazole and amoxicillin provided. These drugs were placed in two boxes, box A and box B, and offered to patients as ordered by the physician. All patients received standard conservative treatment and lumber punctures were performed during the first three days of admission. All patients with cerebrospinal fluid disturbance and meningitis were excluded from the study. Patients were divided into two groups. In the treatment group, patients were given prophylactic antibiotics along with oral cotrimoxazole and amoxicillin. In the control group, patients received standard conservative treatment along with placebo drugs.In cases with cerebrospinal fluid leakage for over 3 days, a lumber puncture was repeated or lumber drain was placed. In cases with signs of meningitis such as fever, purulent discharge, meningismus excluded from study. Another lumbar puncture was performed after ceasing of cerebrospinal fluid leakage and before discharge in the other patients. Patients were examined for headaches and signs of meningitis in their first follow up visit after release. Finally, evaluate efficacy of prophylactic antibiotic in prevention of morbidity and mortality of meningitis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014123020485N1
Registration date: 2015-05-25, 1394/03/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-25, 1394/03/04
Registrant information
Name
Hasan Akbardokht
Name of organization / entity
Ahvaz Jundi Shapur Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3032
Email address
akbardokht.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-02-08, 1393/11/19
Expected recruitment end date
2015-06-19, 1394/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of efficacy of prophylactic antibiotic therapy in prevention of incidence of meningitis in patient with basilar skull fracture and cerebrospinal fluid leakage
Purpose
Prevention
Inclusion/Exclusion 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)
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 346
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jondi Shapour University of Medical Sciences
Street address
Ahvaz medical science university-Golestan-Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2015-02-07, 1393/11/18
Ethics committee reference number
ajums.rec.1393.398

Health conditions studied

1

Description of health condition studied
Fracture of base of skull due to trauma
ICD-10 code
S02.1
ICD-10 code description
Fracture of base of skull

Primary outcomes

1

Description
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 outcomes

1

Description
incidence of meningitis
Timepoint
in course of admision
Method of measurement
with lumbar puncture and analyse of cerebrospinal fuid sample

Intervention groups

1

Description
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 administered daily.
Category
Prevention

2

Description
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 drugs were provided by Ahvaz Jundishapour Medical Universities School of Pharmacy.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Jundishapour Medical University
Full name of responsible person
Dr Akbardokht- Dr Bahrami
Street address
Golestan hospital-Neurosurgery ward
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapour Medical University
Full name of responsible person
Dr Hasan Akbardokht
Street address
Neurosergery ward-Ahvaz Golestan hospital
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapour Medical University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour Medical Sciences University
Full name of responsible person
Dr Hasan Akbardokht
Position
MD- resident of neurosergery
Other areas of specialty/work
Street address
Neurosergery ward-Ahvaz Golestan Hospital
City
ahvaz
Postal code
61357-15749
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
akbardokht@yahoo.com
Web page address
www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour Medical Sciences University
Full name of responsible person
Dr Hasan Akbardokht
Position
MD-Resident of neurosegery
Other areas of specialty/work
Street address
Neyrosegery ward-Ahvaz Golestan Hospital
City
Ahvaz
Postal code
61357-15749
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
akbardokht2yahoo.com
Web page address
www.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour Medical Sciences University
Full name of responsible person
Dr Hasan Akbardokht
Position
MD- Resident of neurosergery
Other areas of specialty/work
Street address
Neurosergery ward-Ahvaz Golestan Hospital
City
Ahvaz
Postal code
61357-15749
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
akbardokht@yahoo.com
Web page address
www.ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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