Comparison of the Efficacy of Oral Ciprofloxacin with Intravenous Cefazolin and Gentamicin for Acute Endophthalmitis Prophylaxis in Patient Referring to Alzahra Ophthalmologic Hospital in 2014
(1) Objective : To compare the efficacy of oral ciprofloxacin with intravenous cefazolin and gentamicin in acute endophthalmitis prophylaxis
(2) Design : Non-randomized , not-blinded , not-placebo-controlled , single-center , phase II - III trial
(3) Setting and conduct :
Participants : All referred patients to Alzahra Eye Hospital in 2014 to 2015 requiring acute endophthalmitis prophylaxis
Inclusion criteria : The need for acute endophthalmitis prophylaxis ; living in Zahedan
Exclusion criteria : All patients who have had eye surgery and other eye diseases ; single-eye patients ; patients who are undergoing medical treatment ; less than 18 years of age ; suspicion for fungal infection ; severe infection
Sample size : 60 patients
(4) Intervention : The eligible patients will be assigned into two thirty patient groups . For group of patients admitted in the service of conductors tablet of ciprofloxacin 500 milligrams twice a day for five days and for patients admitted in the service of other colleagues at Alzahra Eye Hospital intravenous gentamicin 3 mg/kg three times a day and cefazolin 50 mg/kg four times a day for 72 hours will be administered . Patients will be followed for 1 week .
(5) Main outcome measure : incidence of acute endophthalmitis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060818004N1
Registration date:2014-07-13, 1393/04/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-13, 1393/04/22
Registrant information
Name
Mohammad Hossein Validad
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1342 5715
Email address
validad@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Oral Ciprofloxacin with Intravenous Cefazolin and Gentamicin for Acute Endophthalmitis Prophylaxis in Patient Referring to Alzahra Ophthalmologic Hospital in 2014
Public title
Efficacy of Oral Ciprofloxacin in acute endophthalmitis prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : The need for acute endophthalmitis prophylaxis ; living in Zahedan
Exclusion criteria : All patients who have had eye surgery and other eye diseases ; single-eye patients ; patients who are undergoing medical treatment ; less than 18 years of age ; suspicion for fungal infection ; severe infection
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Medical Research Committee of Zahedan University of Medica Sciences
Street address
Dr Hesabi Square , Zahedan University of Medical Sciences Complex
City
Zahedan
Postal code
9816743463
Approval date
2014-04-13, 1393/01/24
Ethics committee reference number
5801
Health conditions studied
1
Description of health condition studied
Purulent Endophthalmitis
ICD-10 code
H44
ICD-10 code description
Panophthalmitis Vitreous abscess
2
Description of health condition studied
Open globe injury
ICD-10 code
S05.4
ICD-10 code description
Penetrating wound of orbit with or without foreign body
Primary outcomes
1
Description
acute endophthalmitis onset
Timepoint
one week
Method of measurement
examination
Secondary outcomes
1
Description
oral ciprofloxacin adverse effects
Timepoint
1 week
Method of measurement
history and examination
2
Description
IV cefazolin and gentamicin adverse effects
Timepoint
1 week
Method of measurement
history , examination and lab test
Intervention groups
1
Description
intervention group : oral Tablet of ciprofloxacin 500 mg twice a day for five days
Category
Treatment - Drugs
2
Description
control group : Intravenous cefazolin 50 mg/kg four times a day and Intravenous gentamicin 80 mg/kg three times a day for 3 days