Study Results
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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COMPLETED
347 participants
OBSERVATIONAL
2011-01-31
2015-08-31
Brief Summary
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Detailed Description
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At enrollment participants will undergo a history and physical examination; blood draw; and pelvic examination including collection of vaginal and cervical samples, STD testing and endometrial biopsy.
Participants will have follow up visits conducted at 1, 4, 8 and 12 months following enrollment. At the follow-up visits, participants will undergo a repeat history and physical, blood draw and pelvic examination including collection of vaginal and cervical samples and STD testing.
The study design will allow comprehensive identification of the antigen-specific cell mediated immune responses most strongly associated with protection against C. trachomatis infection.
The primary objective is to prospectively follow 200 women with or at risk for cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infection.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Risk of positive chlamydia
1. current, untreated endocervical C. trachomatis infection
2. mucopurulent cervicitis on pelvic examination
3. Sexual contact with a male partner recently diagnosed with C. trachomatis, and/or non-gonococcal urethritis
ceftriaxone
250mg IM once
Azithromycin
1 gm once
Interventions
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ceftriaxone
250mg IM once
Azithromycin
1 gm once
Eligibility Criteria
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Inclusion Criteria
2. At least one of the following:
1. Current , untreated endocervical C. trachomatis infection.
2. 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).
3. 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
2. Gynecologic surgery or surgical abortion in preceding 2 months of enrollment.
3. 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.
4. Systemic or vaginal antibiotic therapy in preceding 7 days of enrollment.
5. Prior hysterectomy.
6. Menopause.
7. Any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes.
8. 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.
9. Previous participation in this study.
15 Years
35 Years
FEMALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Harold Wiesenfeld
OTHER
Responsible Party
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Harold Wiesenfeld
Associate Professor
Principal Investigators
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Toni Darville, MD
Role: STUDY_DIRECTOR
University of Pittsburgh
Locations
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Allegheny County Sexually Transmitted Disease Clinic
Pittsburgh, Pennsylvania, United States
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Mercy Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO10010159
Identifier Type: -
Identifier Source: org_study_id