The Role of Novel Organisms in Acute Endometritis

NCT01236131 | Completed

• 2 other identifiers: PRO100804911U19AI084024-01
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to identify the microorganisms present in the endometrial samples obtained from women with or without evidence of endometritis using a combination of culture methods, rRNA sequencing and whole genomic sequencing. The overarching aim of these studies is to identify the etiology of endometritis. The investigators will define the role of fastidious anaerobic microorganisms in the etiology of PID, and assess whether antibiotic treatment regimens used for the treatment of PID have activity against the novel organisms linked with pelvic infections.

Conditions

Pelvic Inflammatory Disease

Outcome Measures

Primary Outcomes (2)

• Identification of Novel Organsims from PRO10010159

  This study will use optimized culture methods which can support the growth of fastidious organisms to describe the microorganisms in endometrial tissue samples obtained from the 200 women enrolled in the cervicitis cohort (PRO10010159, T Cell Response).

  12 months after participant enrollment in PRO10010159

• Identification of Novel Organisms from PRO10010112

  This study will use optimized culture methods which can support the growth of fastidious organisms to describe the microorganisms in endometrial tissue samples obtained from 250 women enrolled in the acute PID study before and after treatment (PRO10010112, Acute PID treatment).

  30 days after participant enrollment in PRO10010112

Study Arms (1)

Endometrial biospy samples

The Endometrial Biopsy samples will be provided by women enrolled in the University of Pittsburgh IRB PRO10010112 and PRO10010159

Other: no intervention

Interventions

no intervention OTHER

Not Applicable- no intervention

Endometrial biospy samples

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Endometrial biopsy samples from women participating in University of Pittsburgh IRB PRO10010112 and PRO10010159

You may qualify if:

• This is a laboratory research study involving the use of biologic specimens only.

You may not qualify if:

• Specimens (endometrial biopsy samples) that are collected from subjects enrolled in PRO10010159 and PRO10010112 that are insufficient will not be included in this study.

Sponsors & Collaborators

• Sharon Hillier: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Magee-Womens Research Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial biopsy specimens and isolates may be retained and stored in various registries such as: 1. Human Microbiome Project 2. J Craig Venture Institute 3. PathoGene 4. American Type Culture Collection 5. CGS MindTouch Wiki hosted on Amazon's Elastic Compute Cloud (http://www.amazon.com/gp/browse.html?node-3435361)52 and will utilize MindTouch's Amazon Machine Image of their Wiki platform for rapid deployment

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Pelvic Infection; Infections; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sharon L Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 8, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

US (1)