Antimicrobial Susceptibility Patterns of N. Gonorrhea Isolates in an Era of Quinolone Resistance

March 6, 2012 updated by: University of Florida

Antimicrobial Susceptibility Patterns of Neisseria Gonorrhea Isolates in an Era of Quinolone Resistance

To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria gonorrhea isolates from men with symptomatic urethritis seen at an STD clinic.

Study Overview

Status

Completed

Conditions

Detailed Description

Until recently, the fluoroquinolones (ofloxacin, ciprofloxacin, levofloxacin) have been the first line oral agents for the empiric treatment of gonorrhea. The prevalence of quinolone resistant Neisseria gonorrheae (QRNG) has been rising since 2000. In 2006, the CDC updated its guidelines to include recommendations against the use of quinolones for treatment of Neisseria gonorrheae. Ceftriaxone (available only by intravenous or intramuscular route) was named as the first line treatment for urogenital and pharyngeal disease. Availability, in the United States, of the other two CDC recommended agents cefixime (oral) and spectinomycin (IM) has been nonexistent.

At this time, there is little data on the in-vitro (laboratory test) susceptibility of antibiotics against gonorrhea, particularly oral drugs. The purpose of this study is to collect specimens of gonorrhea in a non-invasive swab manner from men with symptomatic urethral discharges for laboratory sensitivity testing against a wide array of antibiotic agents.

Specific Aims:

To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria gonorrhea isolates from men with symptomatic urethritis seen at a Duval County STD clinic .

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32206
        • Boulevard Comprehensive Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male patients seen in the Duval County Sexually Transmitted Diseases Clinic with smears positive for gram negative diplococci or unexplained pyuria

Description

Inclusion Criteria:

  • Men between the ages of 18 to 80 years old with suspected urethral gonorrhea by symptoms or gram stained smear

Exclusion Criteria:

  • Patients less than 18 years old or greater than 80 years old
  • Inability to give an informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Christina L Bailey, MD, University of Florida
  • Principal Investigator: Nilmarie Guzman, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H08011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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