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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00692822 |
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 |
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Gonorrhea |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Antimicrobial Susceptibility Patterns of Neisseria Gonorrhea Isolates in an Era of Quinolone Resistance |
Urethral discharge for Neisseria gonorrheae culture
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 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 .
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:
Exclusion Criteria:
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 |
Responsible Party: | University of Florida ( Christina Lynn Bailey, MD / Principal Investigator ) |
Study ID Numbers: | H08011 |
Study First Received: | June 4, 2008 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00692822 |
Health Authority: | United States: Institutional Review Board |
Neisseria gonorrheae Antimicrobial Susceptibility Quinolone Resistance Sexually transmitted diseases |
Genital Diseases, Female Bacterial Infections Disease Susceptibility Sexually Transmitted Diseases Gonorrhea |
Genetic Predisposition to Disease Genital Diseases, Male Gram-Negative Bacterial Infections Neisseriaceae Infections |
Sexually Transmitted Diseases, Bacterial Disease Attributes Pathologic Processes Infection |