Chlamydia Trachomatis Immunology and Vaccinology Study

NCT01150747 | Completed

• 2 other identifiers: PRO10010159U19AI084024
• Study Type: observational
• Target: 347
• Locations: 1 country
• Sites: 4

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 infection. The hypothesis is that a positive IFN-y response by peripheral CD4+ T cells responding to stimulation with HSP60 will be significantly associated with protection from incident C. trachomatis infection.

Conditions

Chlamydia

Outcome Measures

Primary Outcomes (1)

• Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection

  one year per patient

Secondary Outcomes (5)

• Identify immunologic correlates associated with containment of the organism to the lower genital tract

  one year per patient

• Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes

  one year per patient

• Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract

  one year per patient

• Characterize transcriptional inflammatory responses of women with Chlamydia

  Study participation one year per patient

• Use SNP analysis to identify genetic risk factors for chlamydia infection and disease

  Study participation is one year per patient

Study Arms (1)

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

Drug: ceftriaxone; Drug: Azithromycin

Interventions

ceftriaxone DRUG

250mg IM once

Risk of positive chlamydia

Azithromycin DRUG

1 gm once

Risk of positive chlamydia

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women positive for chlamydia or at high risk of chlamydia infection.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harold Wiesenfeld: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (4)

Allegheny County Sexually Transmitted Disease Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Mercy Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Chlamydia Infections

Interventions

Ceftriaxone; Azithromycin

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Toni Darville, MD

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 28, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (4)