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Resistance to Antibiotics in Patients Receiving Eye Injections

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ClinicalTrials.gov Identifier: NCT02126423
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
NJ Retina

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.


Condition or disease Intervention/treatment
Age-Related Macular Degeneration Retinal Vein Occlusion Diabetic Retinopathy Other: Conjunctival and nasopharyngeal swabs

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Prospective Study on Antimicrobial Resistance Rates Following Repeated Courses of Topical Antibiotics for Intravitreal Injection
Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
1st intravitreal injection
Conjunctival and nasopharyngeal swabs are obtained from each treatment-naive patient receiving their 1st intravitreal injection
Other: 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.

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




Primary Outcome Measures :
  1. Kirby Bauer disc diffusion antimicrobial susceptibility [ Time Frame: 15 minutes ]
    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.


Biospecimen Retention:   Samples Without DNA
Conjunctival and nasopharyngeal swabs are procured from each patient.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient setting
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126423


Locations
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United States, New Jersey
NJ Retina
Edison, New Jersey, United States, 08820
Sponsors and Collaborators
NJ Retina
Genentech, Inc.
Investigators
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Principal Investigator: Howard Fine, MD, MHSc NJ Retina

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Responsible Party: NJ Retina
ClinicalTrials.gov Identifier: NCT02126423     History of Changes
Other Study ID Numbers: 1001
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NJ Retina:
Drug Resistance, Microbial

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Macular Degeneration
Diabetic Retinopathy
Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis