Resistance to Antibiotics in Patients Receiving Eye Injections

NCT02126423 | Completed

• 1 other identifier: 1001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-Related Macular Degeneration; Retinal Vein Occlusion; Diabetic Retinopathy

Keywords

Drug Resistance, Microbial

Outcome Measures

Primary Outcomes (1)

• Kirby Bauer disc diffusion antimicrobial susceptibility

  One set of conjunctival and nasopharyngeal swabs obtained from patient shortly after recruitment. Antibiotic susceptibility is determined using the Kirby Bauer disc diffusion method for the following antibiotics: amoxicillin/clavulanate, cefazolin, cefoxitin, erythromycin, moxifloxacin, trimethoprim/sulfamethoxazole, linezolid, clindamycin, and doxycycline.

  15 minutes

Study Arms (2)

1st intravitreal injection

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

Other: Conjunctival and nasopharyngeal swabs

>20 intravitreal injections

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

Other: Conjunctival and nasopharyngeal swabs

Interventions

Conjunctival and nasopharyngeal swabs 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.

1st intravitreal injection; >20 intravitreal injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient setting

You may qualify if:

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

You may not qualify if:

• Those with current use of topical or systemic antibiotics and an active ocular infection or ocular surface disease.

Sponsors & Collaborators

• Prism Vision Group: lead
• Genentech, Inc.: collaborator

Study Sites (1)

NJ Retina

Edison, New Jersey, 08820, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Conjunctival and nasopharyngeal swabs are procured from each patient.

MeSH Terms

Conditions

Macular Degeneration; Retinal Vein Occlusion; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Howard Fine, MD, MHSc

  Prism Vision Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 1, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)