Antimicrobial Susceptibility Patterns of N. Gonorrhea Isolates in an Era of Quinolone Resistance
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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 |
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) |
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 |
Male patients seen in the Duval County Sexually Transmitted Diseases Clinic with smears positive for gram negative diplococci or unexplained pyuria
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| United States, Florida | |
| Boulevard Comprehensive Care Center | |
| Jacksonville, Florida, United States, 32206 | |
| 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 Genetic Predisposition to Disease Gonorrhea Disease Attributes Pathologic Processes Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013