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Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Dr. Peter Kertes, Sunnybrook Health Sciences Centre.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181713
First Posted: August 13, 2010
Last Update Posted: December 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Dr. Peter Kertes, Sunnybrook Health Sciences Centre
  Purpose
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.

Condition
Increased Drug Resistance Infection Resistant to Quinolones and Fluoroquinolones

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections

Resource links provided by NLM:


Further study details as provided by Dr. Peter Kertes, Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 168
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient recruitment would be from the Sunnybrook Health and Sciences Centre Department of Ophthalmology
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
  Contacts and Locations
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): NCT01181713


Locations
Canada, Ontario
Sunnybrook Health and Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Peter Kertes, chief, department of ophthalmology, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01181713     History of Changes
Other Study ID Numbers: SBK-OcuFResis
First Submitted: February 8, 2010
First Posted: August 13, 2010
Last Update Posted: December 5, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents