Status:
COMPLETED
Chlamydia Trachomatis Immunology and Vaccinology Study
Lead Sponsor:
Harold Wiesenfeld
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chlamydia
Eligibility:
FEMALE
15-35 years
Brief Summary
The primary objective is to prospectively follow 200 women with or at risk of cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infectio...
Detailed Description
A total of 200 women with or at high risk of having cervicitis will be prospectively followed for correlations between chlamydia-specific cellular responses and protection against incident infection. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Women 15-35 years of age. Note: Minors must have written informed consent from her parent/legal guardian to participate.
- At least one of the following:
- Current , untreated endocervical C. trachomatis infection.
- Mucopurulent cervicitis: defined by the presence of yellow or green endocervical mucopurulent discharge and/ or easily induced endocervical bleeding (bleeding when the first swab is placed in the endocervix).
- Sexual contact with a male partner (regardless of condom use) recently diagnosed (within the past 3 months) with C. trachomatis and/or non-gonococcal urethritis.
- Exclusion Criteria:
- Pregnant or nursing a baby. Note: a urine pregnancy test will be done at enrollment. Result must be negative to participate in the study.
- Gynecologic surgery or surgical abortion in preceding 2 months of enrollment.
- Allergy to any of the study medications and/or derivatives (cephalosporins, azithromycin, erythromycin, any macrolide or ketolide antibiotic) or Type 1 hypersensitivity allergic reaction to penicillin.
- Systemic or vaginal antibiotic therapy in preceding 7 days of enrollment.
- Prior hysterectomy.
- Menopause.
- Any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes.
- Participation in any study involving an investigational product in the past 30 days or anticipation of participation in any study using an investigational product in the next 30 days.
- Previous participation in this study.
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT01150747
Start Date
January 1 2011
End Date
August 1 2015
Last Update
December 3 2015
Active Locations (4)
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1
Allegheny County Sexually Transmitted Disease Clinic
Pittsburgh, Pennsylvania, United States, 15213
2
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
3
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
4
Mercy Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213