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| Descriptive Information Fields | |||||||||
| Brief Title † | Antimicrobial Susceptibility Patterns of N. Gonorrhea Isolates in an Era of Quinolone Resistance | ||||||||
| Official Title † | Antimicrobial Susceptibility Patterns of Neisseria Gonorrhea Isolates in an Era of Quinolone Resistance | ||||||||
| Brief Summary | To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria gonorrhea isolates from men with symptomatic urethritis seen at an STD clinic. |
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| 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 . |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Case Control, Prospective | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Gonorrhea | ||||||||
| Intervention † | |||||||||
| MEDLINE PMIDs | 14982671, 17342672, 9858344, 15273147, 12184549 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 100 | ||||||||
| Start Date † | June 2008 | ||||||||
| Completion Date | June 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00692822 | ||||||||
| Organization ID | H08011 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of Florida | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of Florida | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | June 4, 2008 | ||||||||
| Last Updated Date | June 4, 2008 | ||||||||
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