Antimicrobial Susceptibility Patterns of N. Gonorrhea Isolates in an Era of Quinolone Resistance - Full Text View

Sponsor:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00692822

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:	Case Control, Prospective
Official Title:	Antimicrobial Susceptibility Patterns of Neisseria Gonorrhea Isolates in an Era of Quinolone Resistance

Resource links provided by NLM:

MedlinePlus related topics: Gonorrhea Sexually Transmitted Diseases

U.S. FDA Resources

Further study details as provided by University of Florida:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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)

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

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

Locations

United States, Florida
Boulevard Comprehensive Care Center	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Katherine E Rogers, BSN 904-253-1261 katherine_rogers@doh.state.fl.us
Contact: Nilmarie Guzman, MD 904-253-1040 nilmarie_guzman@doh.state.fl.us

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:

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.

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. Review.

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.

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.

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

Chin J. Control of Communicable Diseases Manual. 17th ed. American Public Health Association, 2000:223-228

[No authors listed] Sexually transmitted diseases treatment guidelines 2002. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 May 10;51(RR-6):1-78.

Responsible Party:	University of Florida ( Christina Lynn Bailey, MD / Principal Investigator )
Study ID Numbers:	H08011
Study First Received:	June 4, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00692822 History of Changes
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:

Bacterial Infections
Anti-Infective Agents
Sexually Transmitted Diseases, Bacterial
Disease Attributes
Disease Susceptibility
Infection
Genital Diseases, Male
Pharmacologic Actions

Gram-Negative Bacterial Infections
Genital Diseases, Female
Pathologic Processes
Therapeutic Uses
Sexually Transmitted Diseases
Gonorrhea
Genetic Predisposition to Disease
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 27, 2009