Clinical trial NCT00692822: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonorrhea
Keywords: Neisseria gonorrheae
Antimicrobial Susceptibility
Quinolone Resistance
Sexually transmitted diseases
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Boulevard Comprehensive Care Center
state: Florida
Study officials:
affiliation: University of Florida
name: Christina L Bailey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Nilmarie Guzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinstock H, Berman S, Cates W Jr. Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004 Jan-Feb;36(1):6-10. doi: 10.1363/psrh.36.6.04.
citation: Newman LM, Moran JS, Workowski KA. Update on the management of gonorrhea in adults in the United States. Clin Infect Dis. 2007 Apr 1;44 Suppl 3:S84-101. doi: 10.1086/511422.
citation: Tapsall JW, Shultz TR, Limnios EA, Donovan B, Lum G, Mulhall BP. Failure of azithromycin therapy in gonorrhea and discorrelation with laboratory test parameters. Sex Transm Dis. 1998 Nov;25(10):505-8. doi: 10.1097/00007435-199811000-00002.
citation: Ito M, Yasuda M, Yokoi S, Ito S, Takahashi Y, Ishihara S, Maeda S, Deguchi T. Remarkable increase in central Japan in 2001-2002 of Neisseria gonorrhoeae isolates with decreased susceptibility to penicillin, tetracycline, oral cephalosporins, and fluoroquinolones. Antimicrob Agents Chemother. 2004 Aug;48(8):3185-7. doi: 10.1128/AAC.48.8.3185-3187.2004.
citation: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance, 2004. Atlanta, GA: US Dept of Health ands Human Services, September 2005
citation: Hook EW III, Handsfield HH. Gonococcal infections in the adult. In: Holmes KK, Sparling PF, Mardh P, et al. Sexually Transmitted Diseases . 3rd ed. New York: Mc Graw Hill, 1999: 451-66
citation: Chin J. Control of Communicable Diseases Manual. 17th ed. American Public Health Association, 2000:223-228
citation: Sexually transmitted diseases treatment guidelines 2002. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 May 10;51(RR-6):1-78.