NCT00692822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 7, 2012

Status Verified

February 1, 2009

Enrollment Period

1.6 years

First QC Date

June 4, 2008

Last Update Submit

March 6, 2012

Conditions

Gonorrhea

Keywords

Neisseria gonorrheaeAntimicrobial SusceptibilityQuinolone ResistanceSexually transmitted diseases

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Men between the ages of 18 to 80 years old with suspected urethral gonorrhea by symptoms or gram stained smear

You may not qualify if:

  • Patients less than 18 years old or greater than 80 years old
  • Inability to give an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boulevard Comprehensive Care Center

Jacksonville, Florida, 32206, United States

Location

Related Publications (8)

  • 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.

    PMID: 14982671BACKGROUND

  • 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.

    PMID: 17342672BACKGROUND

  • 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.

    PMID: 9858344BACKGROUND

  • 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.

    PMID: 15273147BACKGROUND

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

    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

    BACKGROUND

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

    BACKGROUND

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

    PMID: 12184549BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urethral discharge for Neisseria gonorrheae culture

MeSH Terms

Conditions

GonorrheaSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialCommunicable DiseasesGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christina L Bailey, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Nilmarie Guzman, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

March 7, 2012

Record last verified: 2009-02

Locations

US(1)