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Antibiotic Resistant Patterns of Conjunctival and Nasophayngeal Flora After Repeated Exposure to Topical Antibiotics (ARCaNE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00831961
First Posted: January 29, 2009
Last Update Posted: December 9, 2015
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.
Information provided by (Responsible Party):
Stephen J. Kim, MD, Vanderbilt University
  Purpose

Repeated exposure to topical antibiotics may alter the normal bacteria on the eye and in the nose and increase rates of resistance. This study will determine whether repeated short-term exposure to topical antibiotic drops which are commonly prescribed after eye injections to reduce the chance of infection increase rates of resistant bacteria which are normally found on the eye and in the nose.

We hypothesis that certain commercially available antibiotics may increase rates of bacteria resistance more so than others.


Condition Intervention
Age-related Macular Degeneration Procedure: Conjunctival and nasopharyngeal bacteria cultures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Randomized, Observational Cohort Study of Antibiotic Resistance After Repeated Application of Topical Antibiotics

Resource links provided by NLM:


Further study details as provided by Stephen J. Kim, MD, Vanderbilt University:

Primary Outcome Measures:
  • Establish baseline susceptibility and resistance patterns of normal conjunctival and nasopharyngeal flora of patients with choroidal neovascularization. [ Time Frame: 2 years ]
  • Monitor changes in normal conjunctival and nasopharyngeal flora after repeated exposure to topical antibiotics over a 2 year period. [ Time Frame: 2 ]

Enrollment: 24
Study Start Date: January 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients randomized to gatifloxacin (Zymar)
Procedure: Conjunctival and nasopharyngeal bacteria cultures
Conjunctival and nasopharyngeal bacteria cultures
2
Patients randomized to moxifloxacin (Vigamox)
Procedure: Conjunctival and nasopharyngeal bacteria cultures
Conjunctival and nasopharyngeal bacteria cultures
3
Patients randomized to ofloxacin (Ocuflox)
Procedure: Conjunctival and nasopharyngeal bacteria cultures
Conjunctival and nasopharyngeal bacteria cultures
4
Patients randomized to azithromycin (AzaSite)
Procedure: Conjunctival and nasopharyngeal bacteria cultures
Conjunctival and nasopharyngeal bacteria cultures

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients age greater than 18 with choroidal neovascularization with planned treatment with intravitreal injections.
Criteria

Inclusion Criteria:

  • age greater than 18 with choroidal neovascularization with planned treatment with intravitreal injections

Exclusion Criteria:

  • Use of topical antibiotics for any reason within 3 months, current use of systemic or topical antibiotics, known allergies to gatifloxacin, moxifloxacin, ofloxacin, and azithromycin
  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): NCT00831961


Locations
United States, Tennessee
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Stephen J Kim, MD Vanderbilt University Department of Ophthalmology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen J. Kim, MD, Associate Professor of Ophthalmology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00831961     History of Changes
Other Study ID Numbers: 090020
First Submitted: January 28, 2009
First Posted: January 29, 2009
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Stephen J. Kim, MD, Vanderbilt University:
Antibiotic resistance, Conjunctival flora, Intravitreal injections

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents