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

NCT01160640 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2018-07-10

Study results available
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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.

Conditions

  • Pelvic Inflammatory Disease

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Harold Wiesenfeld

    lead OTHER

Principal Investigators

  • Harold C Wiesenfeld, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01160640 on ClinicalTrials.gov