CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 233 enrolled
Drug / intervention
Ceftriaxone +3 moredrug
Likely dose
Ceftriaxone 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01160640
NCT01160640Phase 2Completed

The Importance of Anti-anaerobic Therapy for Acute PID

Harold Wiesenfeld·interventional·Posted Jul 12, 2010·Updated Jul 10, 2018

In Brief

A Phase 2 clinical trial evaluating Ceftriaxone, Doxycycline, and 2 other interventions for Pelvic Inflammatory Disease. Completed, enrolled 233 participants across 3 sites.

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: 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2010
Enrollment StartNov 1, 2010
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.0 years ago

Interventions

Ceftriaxonedrug

ceftrixone 250mg IM single dose

Doxycyclinedrug

Doxycycline 100 mg PO bid x 14 days

Metronidazoledrug

metronidazole 500 mg PO bid x 14 days

Placebo Oral Capsuledrug

placebo oral capsule PO bid x 14 days