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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:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00831961
First received: January 28, 2009
Last updated: January 13, 2010
Last verified: January 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
  • Monitor changes in normal conjunctival and nasopharyngeal flora after repeated exposure to topical antibiotics over a 2 year period. [ Time Frame: 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stephen J. Kim, Assistant Professor in Ophthalmology, Vanderbilt University Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00831961     History of Changes
Other Study ID Numbers: 090020
Study First Received: January 28, 2009
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Antibiotic resistance, Conjunctival flora, Intravitreal injections

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 18, 2012