NCT01160640

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

The Importance of Anti-anaerobic Therapy for Acute PID

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Harold Wiesenfeld · Academic / Other
• Sex: Female
• Age: 15 Years – 40 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Pelvic Inflammatory Disease

Interventions

Type	Name	Description
DRUG	Ceftriaxone	ceftrixone 250mg IM single dose
DRUG	Doxycycline	Doxycycline 100 mg PO bid x 14 days
DRUG	Metronidazole	metronidazole 500 mg PO bid x 14 days
DRUG	Placebo Oral Capsule	placebo oral capsule PO bid x 14 days

Timeline

• Start date: 2010-11-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2010-07-12
• Last updated: 2018-07-10
• Results posted: 2016-12-21

Locations

3 sites across 1 country: United States