ChlamydiaNCT01150747
Chlamydia Trachomatis Immunology and Vaccinology Study
An observational study of Chlamydia, run by Harold Wiesenfeld at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- Chlamydia
- What is being tested?
- ceftriaxone and Azithromycin
- How many people
- 347 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2011to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women positive for chlamydia or at high risk of chlamydia infection.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Allegheny County Sexually Transmitted Disease Clinic
Pittsburgh, Pennsylvania, 15213
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Mercy Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Chlamydia Trachomatis Immunology and Vaccinology Study: Determination of Protective T Cell Responses to Chlamydia Trachomatis Infection
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.
Read the 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.
- Conditions
- Chlamydia
- Being tested
- ceftriaxone, Azithromycin
- Medical subject headings
- Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxoneDrug
250mg IM once
AzithromycinDrug
1 gm once
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ceftriaxone; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection
Measured: one year per patient
Secondary outcomes (5)
Identify immunologic correlates associated with containment of the organism to the lower genital tract
Measured: one year per patient
Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes
Measured: one year per patient
Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract
Measured: one year per patient
Characterize transcriptional inflammatory responses of women with Chlamydia
Measured: Study participation one year per patient
Use SNP analysis to identify genetic risk factors for chlamydia infection and disease
Measured: Study participation is one year per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlamydiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harold Wiesenfeld
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Harold Wiesenfeld, University of Pittsburgh
- Investigators
- Toni Darville, MD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150747
- Sponsor's protocol ID
- PRO10010159
- Other IDs
- U19AI084024
- Status last verified
- Dec 2015
- First submitted
- 23 Jun 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlamydia Trachomatis Immunology and Vaccinology Study: Determination of Protective T Cell Responses to Chlamydia Trachomatis Infection
- ClinicalTrials.gov ID
- NCT01150747
- Acronym / sponsor ID
- PRO10010159
- Conditions
- Chlamydia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Harold WiesenfeldUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk of positive chlamydia | – | Drug: ceftriaxone, Drug: Azithromycin1. 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 |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women positive for chlamydia or at high risk of chlamydia infection.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftriaxone250mg IM once | Drug | Risk of positive chlamydia |
| Azithromycin1 gm once | Drug | Risk of positive chlamydia |
Primary outcome
Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection
Time frame: one year per patient
5 secondary outcomes
Identify immunologic correlates associated with containment of the organism to the lower genital tract
Time frame: one year per patient
Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes
Time frame: one year per patient
Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract
Time frame: one year per patient
Characterize transcriptional inflammatory responses of women with Chlamydia
Time frame: Study participation one year per patient
Use SNP analysis to identify genetic risk factors for chlamydia infection and disease
Time frame: Study participation is one year per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toni Darville, MD study director
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydia, run by Harold Wiesenfeld at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection (time frame: one year per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.