Resistance to Antibiotics in Patients Receiving Eye Injections

NCT ID: NCT02126423

Last Updated: 2016-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-09-30

Brief Summary

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The administration of short courses of topical antibiotic drops before and/or after intravitreal injections is a common practice, but increasing evidence suggests this may not lower the risk of infectious endophthalmitis and could increase rates of antimicrobial resistance. The purpose of the present study is to determine the antimicrobial resistance profiles in patients who have received numerous (≥ 20) courses of antibiotics for intravitreal injection compared with untreated controls.

This study compares 20 control patients without prior intravitreal injection to 20 patients who have undergone ≥ 20 prior intravitreal injections accompanied by a course of topical antibiotics for two days before and/or after the injection procedure. The lower, inner eyelid and nasal cavity were cultured and evaluated via disk diffusion method for antimicrobial sensitivity.

Detailed Description

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Before administration of anti-VEGF therapy (Vascular Endothelial Growth Factor) or topical antibiotics, conjunctival and nasopharyngeal swabs are procured with the Bacti-Swab transport system (Thermo Fisher Scientific, Waltham, MA). For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.

Culture swabs are then plated onto 5% sheep blood plates and incubated at 37°C for 3 days. Colonies are isolated and identified with API (Analytical Profile Index) Microbial Identification Kits (bioMérieux Inc., Hazelwood, MO). Antibiotic susceptibility is determined using the Kirby Bauer disc diffusion method. Additional data collected includes age, ocular and systemic medical conditions, and the number of intravitreal injections along with anti-VEGF agents used.

Statistical calculations for antibiotic resistance comprises of t-test and and multivariate analysis.

Conditions

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Age-Related Macular Degeneration Retinal Vein Occlusion Diabetic Retinopathy

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1st intravitreal injection

Conjunctival and nasopharyngeal swabs are obtained from each treatment-naive patient receiving their 1st intravitreal injection

Conjunctival and nasopharyngeal swabs

Intervention Type OTHER

For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.

>20 intravitreal injections

Conjunctival and nasopharyngeal swabs are obtained from each patient with \>20 intravitreal injection therapies.

Conjunctival and nasopharyngeal swabs

Intervention Type OTHER

For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.

Interventions

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Conjunctival and nasopharyngeal swabs

For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (above age 18) diagnosed with age-related macular degeneration and receiving their 1st or 20th (or \>20th) intravitreal injection therapy.

Exclusion Criteria

* Those with current use of topical or systemic antibiotics and an active ocular infection or ocular surface disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Prism Vision Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Fine, MD, MHSc

Role: PRINCIPAL_INVESTIGATOR

Prism Vision Group

Locations

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NJ Retina

Edison, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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1001

Identifier Type: -

Identifier Source: org_study_id

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