Pelvic Inflammatory DiseaseNCT01236131
The Role of Novel Organisms in Acute Endometritis
An observational study of Pelvic Inflammatory Disease, run by Sharon Hillier at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Endometrial biopsy samples from women participating in University of Pittsburgh IRB PRO10010112 and PRO10010159
Who may be able to join
- 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.
Who cannot join
- Specimens (endometrial biopsy samples) that are collected from subjects enrolled in PRO10010159 and PRO10010112 that are insufficient will not be included in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Research Institute
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Characterization of Novel Organisms in the Genital Tract of Women With PID and Determination of Their Association With Endometritis.
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
- Being tested
- no intervention
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Not Applicable- no intervention
| Study group | Role | What they receive |
|---|---|---|
| Endometrial biospy samples | The Endometrial Biopsy samples will be provided by women enrolled in the University of Pittsburgh IRB PRO10010112 and PRO10010159 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 30 days after participant enrollment in PRO10010112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Hillier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sharon Hillier, University of Pittsburgh
- Investigators
- Sharon L Hillier, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236131
- Sponsor's protocol ID
- PRO10080491
- Other IDs
- 1U19AI084024-01
- Status last verified
- Aug 2016
- First submitted
- 4 Nov 2010
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Novel Organisms in the Genital Tract of Women With PID and Determination of Their Association With Endometritis.
- ClinicalTrials.gov ID
- NCT01236131
- Acronym / sponsor ID
- PRO10080491
- Conditions
- Pelvic Inflammatory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Sharon HillierUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial biospy samples | – | Other: no interventionThe Endometrial Biopsy samples will be provided by women enrolled in the University of Pittsburgh IRB PRO10010112 and PRO10010159 |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Endometrial biopsy samples from women participating in University of Pittsburgh IRB PRO10010112 and PRO10010159
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Specimens (endometrial biopsy samples) that are collected from subjects enrolled in PRO10010159 and PRO10010112 that are insufficient will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNot Applicable- no intervention | Other | Endometrial biospy samples |
Primary outcome
Identification of Novel Organsims from PRO10010159
Time frame: 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).
Identification of Novel Organisms from PRO10010112
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
Related trials for Pelvic Inflammatory Disease
Not yet recruitingPhase 4
ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
Ulcerative Colitis (UC), Pouchitis
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Cervical Carcinoma, Endometrial Carcinoma
RecruitingPhase 1/2
Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Endometriosis, Adenomyosis
Not yet recruiting
Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
Cesarean Section, Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon L Hillier, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Inflammatory Disease, run by Sharon Hillier at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Novel Organsims from PRO10010159 (time frame: 12 months after participant enrollment in PRO10010159). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.