Clinical Trial: The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Importance of Anti-anaerobic Therapy for Acute PID

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 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.

Detailed 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. 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.
Sponsor: Harold Wiesenfeld

Current Primary Outcome: 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.


Original Primary Outcome: Clearance of Anaerobic Organisms From the Endometrium [ Time Frame: 30 days ]

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome:

  • The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID. [ Time Frame: enrollment ]
  • b. The eradication of M. genitalium from the lower and upper genital tract following antibiotic therapy for acute PID. [ Time Frame: 30 day follow up visit ]
  • Resolution of clinical signs and symptoms of acute PID [ Time Frame: 3 day follow up visit ]


Information By: University of Pittsburgh

Dates:
Date Received: July 8, 2010
Date Started: November 2010
Date Completion:
Last Updated: December 28, 2016
Last Verified: October 2016