- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01160640
The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
July 6, 2018 updated by: Harold Wiesenfeld
The Importance of Anti-anaerobic Therapy for Acute PID
This study is a randomized placebo-controlled trial comparing two antibiotic treatment regimens for acute PID.
Women with acute PID will be randomized to one of two treatment regimens: 1) a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally twice a day for 14 days, along with placebo tablets orally twice a day for 14 days or 2) same doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14 days.
The primary objective is to compare the eradication of anaerobic organisms from the upper genital tract between women who receive standard outpatient antibiotic treatment to those who receive standard outpatient treatment along with a two-week course of metronidazole.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized placebo-controlled trial comparing two antibiotic treatment regimens for acute PID.
Women with acute PID will be randomized to one of two treatment regimens.
One group of women will receive a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally twice a day for 14 days, along with placebo tablets orally twice a day for 14 days.
The second group of women will receive the same doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14 days.
The primary objective is to compare the eradication of anaerobic organisms from the upper genital tract in women with acute PID who receive standard outpatient antibiotic treatment to the eradication of these organisms from the upper genital tract in women who receive standard outpatient treatment along with a two-week course of metronidazole.
Women will be followed for one month for clinical outcomes, and will undergo assessment for clearance of microorganisms from the upper genital tract.
Our hypothesis is that an antibiotic treatment regimen that includes anaerobic coverage will more effectively clear anaerobic organisms from the endometrium in women with acute PID compared to a standard antibiotic treatment regimen lacking effective antibiotic coverage against anaerobes.
Study Type
Interventional
Enrollment (Actual)
233
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital of UPMC
-
Pittsburgh, Pennsylvania, United States, 15213
- Allegheny County Health Department Sexually Transmitted Diseases Clinic
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Pittsburgh, Pennsylvania, United States, 15219
- UPMC Mercy Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Women must meet all of the following inclusion criteria:
- Age 15-40 at the time of enrollment (Note: Participants between the ages of 15-17 will require written informed consent from parent/legal guardian. Written assent will also be obtained from the minor)
Acute PID, defined by symptoms and signs guided by current CDC guidelines:50
- Current symptoms of lower abdominal or pelvic pain (present for ≤30 days) AND
- Cervical motion tenderness AND/OR uterine tenderness AND/OR adnexal tenderness on pelvic examination
- Ability to provide written informed consent
Exclusion Criteria:
Women with any of the following will be ineligible to participate:
- Pregnant or nursing a baby (Note: a urine pregnancy test will be done at enrollment. Result must be negative to participate in the study.)
- Uterine procedure (e.g. dilation and curettage, abortion) or miscarriage within the past 6 weeks.
- Allergy to any of the study medications (cephalosporins, doxycycline, or metronidazole) or Type 1 hypersensitivity allergic reaction to penicillin for those with unknown tolerance to cephalosporins.
- Systemic or vaginal antibiotic therapy in the preceding 7 days
- Requires inpatient PID therapy (per the current CDC guidelines)50
- Inability to obtain an endometrial biopsy at enrollment
- Known inability to comply with the follow-up visits
- Prior hysterectomy
- Menopause (including natural menopause defined as lack of menses for 12 consecutive months [in the absence of pregnancy] and surgical menopause defined as a woman who has had both ovaries removed)
- Inability to swallow pills
- Not willing to refrain from alcohol during the two week treatment period (and two additional days following completion of study medication)
- Other condition present at enrollment that requires additional antibiotic treatment
Current use of any of the following medications:
- Anticoagulants, coumarin- or indandione-derivative: warfarin
- cimetidine (Tagamet)
- Disulfiram
- Seizure medications including: phenytoin (Dilantin), carbamezapine (Tegretol), barbiturates (i.e. Phenobarbital)
- Lithium
- Immunosuppressive drugs including: cyclosporine, amprenavir
- Antacids, minerals or bismuth subsalicylate (Pepto Bismol)
- Any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes
- Participation in any study involving an investigational product in the past 30 days or anticipation of participation in any study using an investigational product in the next 30 days
- Previous participation in this study
- Evidence of a tuboovarian abscess
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Ceftriaxone/Doxycycline/Placebo Oral Cap
ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo oral capsule PO bid x 14 days
|
ceftrixone 250mg IM single dose
Other Names:
Doxycycline 100 mg PO bid x 14 days
placebo oral capsule PO bid x 14 days
|
Active Comparator: Ceftriaxone, Doxycycline, Metronidazole
ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
|
ceftrixone 250mg IM single dose
Other Names:
Doxycycline 100 mg PO bid x 14 days
metronidazole 500 mg PO bid x 14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clearance of Anaerobic Organisms From the Endometrium
Time Frame: Enrollment to 30 days
|
Clearance of anaerobic microorganisms from the endometrium at the 30 day follow-up visit among women who had anaerobic microorganisms detected in their endometrial tissue sample at enrollment.
Clearance is defined as no anaerobic microorganisms detected in the endometrial tissue biopsy sample collected at the 30-day visit.
|
Enrollment to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.
Time Frame: enrollment
|
The number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.
|
enrollment
|
The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.
Time Frame: Enrollment to 30 days
|
M. genitalium not detected in the cervical and endometrial cultures by nucleic acid amplification testing at the 30 day visit among women who had M. genitalium detected at either anatomical site at the enrollment visit.
|
Enrollment to 30 days
|
Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis
Time Frame: Enrollment to 3 day follow up visit
|
Clinical response to treatment is improvement (reduction) of the McCormack Scale total score from baseline to day 3 follow-up visit.
Participants without a 3-day measure were considered treatment failures.
|
Enrollment to 3 day follow up visit
|
Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.
Time Frame: enrollment
|
Identification of endometrial microorganisms present obtained from women with or without evidence of endometritis using a combination of culture methods, rRna sequencing and whole genomic sequencing.
The aim is to identify the etiology of endometritis.
|
enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harold C Wiesenfeld, MD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
July 8, 2010
First Submitted That Met QC Criteria
July 9, 2010
First Posted (Estimate)
July 12, 2010
Study Record Updates
Last Update Posted (Actual)
July 10, 2018
Last Update Submitted That Met QC Criteria
July 6, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO10010112
- 1U19AI084024-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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