The Role of Novel Organisms in Acute Endometritis

• Sponsor: Sharon Hillier (Other)
• Overall Status: Completed
• CT.gov ID: NCT01236131
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 480
• Location: 1
• Duration (Months): 57
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Inflammatory Disease	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 480 participants
• Time Perspective: Cross-Sectional
• Official Title: Characterization of Novel Organisms in the Genital Tract of Women With PID and Determination of Their Association With Endometritis.
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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; Not Applicable- no intervention

Outcome Measures

Primary Outcome Measures

1. Identification of Novel Organsims from PRO10010159 [12 months after participant enrollment in 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).

2. Identification of Novel Organisms from PRO10010112 [30 days after participant enrollment in 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee-Womens Research Institute	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Sharon L Hillier, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sharon Hillier, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01236131
• Other Study ID Numbers: PRO10080491; 1U19AI084024-01
• First Posted: Nov 7, 2010
• Last Update Posted: Aug 17, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection; Endometritis

Study Results

No Results Posted as of Aug 17, 2016