drugset / Trial / NCT00398658

Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

NCT00398658 ↗

RandomizedParallel-groupDouble-blind

Summary

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.

Timeline

Start
2002-03
Primary completion
—
Completion
2004-12

Outcome

Met primary endpoint

paper Endophthalmitis occurred in 8 (2.3%) of 167 eyes in the control group and only in 1 (0.3%) of 179 eyes PMID 17420365 ↗

paper the case group (P = .04; odds ratio, 8.93 [95% confidence interval, 1.11-71.43]). PMID 17420365 ↗

paper Intraocular gentamicin and clindamycin are effective in the prevention of acute posttraumatic bacterial endophthalmitis PMID 17420365 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clindamycin Unknown 45 ug Other
Subject Gentamicin Small molecule 40 ug Other

Indications