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Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

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ClinicalTrials.gov Identifier: NCT01181713
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Dr. Peter Kertes, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date February 8, 2010
First Posted Date August 13, 2010
Last Update Posted Date March 18, 2021
Study Start Date June 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2010)
ocular flora resistance to 4th generation fluoroquinolone [ Time Frame: 1 year ]
Outcome will examine the change in amount, type and antibiotic resistance profile of ocular surface flora over the 3 months. Charcoal swab of the conjunctiva will be cultured, organisms grown will be identified and resistance to moxifloxacin will be quantified by minimal inhibitory resistance (MIC).
Original Primary Outcome Measures
 (submitted: August 11, 2010)
ocular flora resistance to 4th generation fluoroquinolone [ Time Frame: pre and post intravitreal injection for 3 months ]
Outcome will examine the change in amount, type and antibiotic resistance profile of ocular surface flora over the 3 months. Charcoal swab of the conjunctiva will be cultured, organisms grown will be identified and resistance to moxifloxacin will be quantified by minimal inhibitory resistance (MIC).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use
Official Title Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections
Brief Summary The purpose of this study is to determine if antibiotic resistance of the ocular surface flora to the 4th generation fluoroquinolones will increase after repeated use of topical antibiotics for three days post intravitreal injection.
Detailed Description

Treatment with intravitreal (IVT) injections has increased during the last several years as evidence has accumulated demonstrating the efficacy of anti-vascular endothelial growth factor agents in the treatment of neovascular age-related macular degeneration (AMD) and various retinal vascular diseases.

Although IVT injections are generally safe, infectious endophthalmitis is a rare but devastating complication, and the risk of morbidity and vision loss from endophthalmitis is high. The objective is to examine the change in antibiotic resistance of ocular surface flora with repeated prophylactic use of antibiotics after IVT injection for AMD.

Yin, V. T., Weisbrod, D. J., Eng, K. T., Schwartz, C., Kohly, R., Mandelcorn, E., Lam, W., Daneman, N., Simor, A., & Kertes, P. J. (2013). Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA ophthalmology, 131(4), 456-461.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient recruitment would be from the Sunnybrook Health and Sciences Centre Department of Ophthalmology
Condition
  • Increased Drug Resistance
  • Infection Resistant to Quinolones and Fluoroquinolones
Intervention Not Provided
Study Groups/Cohorts
  • No Antibiotic
    No prophylactic antibiotic post intravitreal injection
  • Prophylactic Antibiotic
    Group treated with 3 day course of prophylactic topic antibiotic, fourth generation fluoroquinolones, after each intravitreal injection
Publications * Yin VT, Weisbrod DJ, Eng KT, Schwartz C, Kohly R, Mandelcorn E, Lam WC, Daneman N, Simor A, Kertes PJ. Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA Ophthalmol. 2013 Apr;131(4):456-61. doi: 10.1001/jamaophthalmol.2013.2379.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 16, 2021)
200
Original Estimated Enrollment
 (submitted: August 11, 2010)
168
Actual Study Completion Date December 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients scheduled for intravitreal injection for neovascular age-related macular degeneration (ARMD)
  • 65 years or older
  • able to provide informed consent.

Exclusion Criteria:

  • diagnosed with an active ocular, periocular or systemic infection
  • previously received treatment with an intravitreal injection
  • previously treated with antibiotics in the past three months
  • unable to attend the scheduled follow-up appointments or to complete treatment for any reason
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01181713
Other Study ID Numbers SBK-OcuFResis
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Peter Kertes, Sunnybrook Health Sciences Centre
Study Sponsor Sunnybrook Health Sciences Centre
Collaborators Novartis
Investigators
Study Chair: Peter Kertes, MD, FRCSC Sunnybrook Health Sciences Centre
Study Director: Vivian T Yin, MD University of Toronto
Study Director: Daniel Weisbrod, MD, FRCSC Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date March 2021