Chlamydia Trachomatis Immunology and Vaccinology Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Harold Wiesenfeld, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01150747
First received: June 23, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Chlamydia
Drug: ceftriaxone
Drug: Azithromycin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Chlamydia Trachomatis Immunology and Vaccinology Study: Determination of Protective T Cell Responses to Chlamydia Trachomatis Infection

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection [ Time Frame: one year per patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify immunologic correlates associated with containment of the organism to the lower genital tract [ Time Frame: one year per patient ] [ Designated as safety issue: No ]
  • Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes [ Time Frame: one year per patient ] [ Designated as safety issue: No ]
  • Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract [ Time Frame: one year per patient ] [ Designated as safety issue: No ]
  • Characterize transcriptional inflammatory responses of women with Chlamydia [ Time Frame: Study participation one year per patient ] [ Designated as safety issue: No ]
  • Use SNP analysis to identify genetic risk factors for chlamydia infection and disease [ Time Frame: Study participation is one year per patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: January 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
250mg IM once
Drug: Azithromycin
1 gm once

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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria

  1. Women 15-35 years of age. Note: Minors must have written informed consent from her parent/legal guardian to participate.
  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:

  1. Pregnant or nursing a baby. Note: a urine pregnancy test will be done at enrollment. Result must be negative to participate in the study.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150747

Contacts
Contact: Ingrid Macio, PA-C 412-641-5455 imacio@mail.magee.edu
Contact: Jamie Haggerty 412-641-5378 jhaggerty@mail.magee.edu

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455    imacio@mail.magee.edu   
Contact: Jamie Haggerty    412-641-5378    jhaggerty@mail.magee.edu   
Sub-Investigator: Sharon Achilles, MD         
Sub-Investigator: Katherine Bunge, MD         
Principal Investigator: Toni Darville, MD         
Sub-Investigator: Sharon L Hillier, PhD         
Sub-Investigator: Ingrid Macio, PA-C         
Sub-Investigator: Carol Priest, CRNP         
Principal Investigator: Harold C Wiesenfeld, MD         
Sub-Investigator: Julie McKechnie, CNM         
Magee Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455      
Allegheny County Sexually Transmitted Disease Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455    imacio@mail.magee.edu   
Mercy Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455      
Sponsors and Collaborators
Harold Wiesenfeld
Investigators
Study Director: Toni Darville, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Harold Wiesenfeld, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01150747     History of Changes
Other Study ID Numbers: PRO10010159, U19AI084024
Study First Received: June 23, 2010
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014