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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI084024 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk of positive chlamydia |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftriaxone | Drug | 250mg IM once |
| |
| Azithromycin |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection | one year per patient |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria:
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Women positive for chlamydia or at high risk of chlamydia infection.
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| Name | Affiliation | Role |
|---|---|---|
| Toni Darville, MD | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny County Sexually Transmitted Disease Clinic | Pittsburgh | Pennsylvania | 15213 | United States | ||
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| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| Drug |
1 gm once |
|
| 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 |
| Magee Womens Hospital of UPMC |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Mercy Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |