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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00692822
First received: June 4, 2008
Last updated: March 6, 2012
Last verified: February 2009
  Purpose

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


Condition
Gonorrhea

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antimicrobial Susceptibility Patterns of Neisseria Gonorrhea Isolates in an Era of Quinolone Resistance

Resource links provided by NLM:


Further study details as provided by University of Florida:

Biospecimen Retention:   Samples Without DNA

Urethral discharge for Neisseria gonorrheae culture


Enrollment: 60
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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 .

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692822

Locations
United States, Florida
Boulevard Comprehensive Care Center
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Christina L Bailey, MD University of Florida
Principal Investigator: Nilmarie Guzman, MD University of Florida
  More Information

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00692822     History of Changes
Other Study ID Numbers: H08011
Study First Received: June 4, 2008
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Neisseria gonorrheae
Antimicrobial Susceptibility
Quinolone Resistance
Sexually transmitted diseases

Additional relevant MeSH terms:
Disease Susceptibility
Gonorrhea
Bacterial Infections
Disease Attributes
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Infection
Neisseriaceae Infections
Pathologic Processes
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014