Antimicrobial Susceptibility Patterns of N. Gonorrhea Isolates in an Era of Quinolone Resistance

NCT ID: NCT00692822

Last Updated: 2012-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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 .

Conditions

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Gonorrhea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina L Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Nilmarie Guzman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Boulevard Comprehensive Care Center

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14982671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17342672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9858344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15273147 (View on PubMed)

Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance, 2004. Atlanta, GA: US Dept of Health ands Human Services, September 2005

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Sexually transmitted diseases treatment guidelines 2002. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 May 10;51(RR-6):1-78.

Reference Type BACKGROUND
PMID: 12184549 (View on PubMed)

Other Identifiers

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H08011

Identifier Type: -

Identifier Source: org_study_id

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