The Role of Novel Organisms in Acute Endometritis

Pelvic Inflammatory Disease Clinical Trial

Official title:

Characterization of Novel Organisms in the Genital Tract of Women With PID and Determination of Their Association With Endometritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236131
• Other study ID #: PRO10080491
• Secondary ID: 1U19AI084024-01
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: August 15, 2016
• Start date: November 2010
• Est. completion date: August 2015

Study information

• Verified date: August 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

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

• Specimens (endometrial biopsy samples) collected from subjects who meet the inclusion criteria for PRO10010159 and PRO10010112 will be utilized for this study.

Exclusion Criteria:

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Endometritis
• Pelvic Inflammatory Disease

Intervention

Other:
• no intervention
Not Applicable- no intervention

Locations

Country	Name	City	State
United States	Magee-Womens Research Institute	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sharon Hillier	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No