The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID) (NCT01160640) | Clinical Trial Compass
CompletedPhase 2
The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
United States233 participantsStarted 2010-11
Plain-language 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 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.
Who can participate
Age range15 Years – 40 Years
SexFEMALE
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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
✕. 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.
What they're measuring
1
Clearance of Anaerobic Organisms From the Endometrium