Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

This study has been completed.

First Received: November 13, 2006 Last Updated: October 17, 2008 History of Changes

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00398658

Purpose

Purpose: To evaluate the efficacy of combined intraocular injection of gentamycin and clindamycin in prevention of acute posttraumatic bacterial endophthalmitis (APBE) following penetrating eye injuries. Design: Multicenter, randomized, double masked, controlled trial. Participants: Three hundred forty six eyes of 346 patients with penetrating eye injury.

Method: Following primary repair, eyes were randomized to receive a 0.1 ml intracameral or intravitreal injection of 40µg gentamycin and 45µg clindamycin (cases), versus intracameral or intravitreal injection of 0.1ml balanced saline solution (controls). All patients received standard prophylactic antibiotic therapy (systemic, subconjunctival and topical). Main outcome measures: Occurrence of endophthalmitis within two weeks after primary repair.

Condition	Intervention	Phase
Endophthalmitis Prophylaxy of Post Traumatic Endophthalmitis Bacterial Endophthalmitis	Drug: gentamycin and clindamycin	Phase IV

MedlinePlus related topics: Antibiotics Eye Injuries

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Gentamicins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Shaheed Beheshti Medical University:

Study Start Date:	March 2002
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients with penetrating eye injuries referred to collaborating institutes for primary repair

Exclusion Criteria:

Absence of light perception
presence of endophthalmitis at the time of initial evaluation
total corneal opacity
age under 3 years
severe intracameral hemorrhage
history of intraocular surgery and presence of a corneal ulcer
Monocular patients
the better eye in simultaneous bilateral injuries

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398658

Locations

Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Masoud Soheilian, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided by Shaheed Beheshti Medical University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Soheilian M, Rafati N, Mohebbi MR, Yazdani S, Habibabadi HF, Feghhi M, Shahriary HA, Eslamipour J, Piri N, Peyman GA; Traumatic Endophthalmitis Trial Research Group. Prophylaxis of acute posttraumatic bacterial endophthalmitis: a multicenter, randomized clinical trial of intraocular antibiotic injection, report 2. Arch Ophthalmol. 2007 Apr;125(4):460-5.

Study ID Numbers:	8019
Study First Received:	November 13, 2006
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00398658 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

Endophthalmitis
Post-traumatic Endophthalmitis
Bacterial Endophthalmitis
Prophylaxis of Endophthalmitis
Intra Ocular Injection of antibiotics

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Mycoses
Eye Infections, Bacterial
Clindamycin
Clindamycin-2-phosphate

Uveitis
Eye Diseases
Gentamicins
Eye Infections
Endophthalmitis
Suppuration

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Eye Infections, Bacterial
Uveal Diseases
Clindamycin
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Eye Infections
Endophthalmitis
Enzyme Inhibitors

Infection
Eye Infections, Fungal
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Mycoses
Uveitis
Therapeutic Uses
Gentamicins
Uveitis, Suppurative

ClinicalTrials.gov processed this record on May 07, 2009