drugset / Trial / NCT01160640

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

NCT01160640

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-11
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metronidazole Small molecule 500 mg Oral
Comparator Ceftriaxone Other / unclassified 250 mg Intramuscular
Comparator Doxycycline Small molecule 100 mg Oral