Status:
COMPLETED
The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
Lead Sponsor:
Harold Wiesenfeld
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pelvic Inflammatory Disease
Eligibility:
FEMALE
15-40 years
Phase:
PHASE2
Brief Summary
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 int...
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 wo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT01160640
Start Date
November 1 2010
End Date
August 1 2015
Last Update
July 10 2018
Active Locations (3)
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1
Allegheny County Health Department Sexually Transmitted Diseases Clinic
Pittsburgh, Pennsylvania, United States, 15213
2
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
3
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219