The objective of the Clinical Core is to provide the clinical resources for the individual research projects within the Sexually Transmitted Infections Cooperative Research Center (STI CRC). The Clinical Core will assemble a cohort of 250 women with acute PID to participate in a randomized controlled trial of two antibiotic regimens for the treatment of acute PID (Project 1). This cohort will also serve as the source for specimens for Project 2, examining novel previously uncultivatable organisms in endometritis. The Clinical Core will also construct a cohort of 200 women with or at-risk for Chlamydia trachomatis infection to determine the antigen-specific cell mediated immune resposes that are most strongly associated with protection against C. trachomatis infection and to elucidate the antigen specifc immune responses correlated with containment of C. trachomatis infection to the lower genital tract (Project 4). To accomplish its goal of recruiting participants and collecting specimens to meet each of the projects'goals, the Clinical Core has assembled reecruitment sites that are the major providers of reproductive health care in our region, and are sites that are successful in the conduct of STI research. The Clinical Core will perform the vaginal and endometrial cultures and the STI diagnostic testing in support of Projects 1, 2 and 4. The Clinical Core personnel consists of a physician research, a PhD microbiologist, two nurse practitioners and research assistants who have extensive experience in STI research and the conduct of large clinical trials. ? By using a single research team and a network of clinical sites with provien ability to recruit participants for STD research, the Clinical Core will be able to successfully recruit research participants to meet the individual needs of the projects of this STI CRC application.

Public Health Relevance

The Clinical Core has assembled an experienced team of researchers who will recruit 450 participants in two clinical trials to support the needs of the research projects in this application. This well-structured operation has extensive experience in STI research and will ensure the successful recruitment of participants and collection of specimens to assure the successful completion of the research projects in this application.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI084024-05
Application #
8529455
Study Section
Special Emphasis Panel (ZAI1-MMT-M)
Project Start
Project End
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
5
Fiscal Year
2013
Total Cost
$730,630
Indirect Cost
$136,021
Name
University of Pittsburgh
Department
Type
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Barral, Romina; Desai, Ruchi; Zheng, Xiaojing et al. (2014) Frequency of Chlamydia trachomatis-specific T cell interferon-? and interleukin-17 responses in CD4-enriched peripheral blood mononuclear cells of sexually active adolescent females. J Reprod Immunol 103:29-37
Darville, Toni (2013) Recognition and treatment of chlamydial infections from birth to adolescence. Adv Exp Med Biol 764:109-22
Darville, Toni; Pelvic Inflammatory Disease Workshop Proceedings Committee (2013) Pelvic inflammatory disease: identifying research gaps--proceedings of a workshop sponsored by Department of Health and Human Services/National Institutes of Health/National Institute of Allergy and Infectious Diseases, November 3-4, 2011. Sex Transm Dis 40:761-7
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Riley, Melissa M; Zurenski, Matthew A; Frazer, Lauren C et al. (2012) The recall response induced by genital challenge with Chlamydia muridarum protects the oviduct from pathology but not from reinfection. Infect Immun 80:2194-203
Taylor, Brandie D; Darville, Toni; Ferrell, Robert E et al. (2012) Variants in toll-like receptor 1 and 4 genes are associated with Chlamydia trachomatis among women with pelvic inflammatory disease. J Infect Dis 205:603-9
Tuttle, Marie S; Mostow, Eliot; Mukherjee, Pranab et al. (2011) Characterization of bacterial communities in venous insufficiency wounds by use of conventional culture and molecular diagnostic methods. J Clin Microbiol 49:3812-9
Chavez, Jean M; Vicetti Miguel, Rodolfo D; Cherpes, Thomas L (2011) Chlamydia trachomatis infection control programs: lessons learned and implications for vaccine development. Infect Dis Obstet Gynecol 2011:754060

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