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Empiric Therapy of Mucopurulent Cervicitis (MPC)

NCT01072136 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2014-12-24

Study results available
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Summary

Mucopurulent cervicitis (MPC) is a syndrome with associated symptoms including mucopurulent discharge (mucus and pus) from the cervix and other signs of inflammation such as easily induced cervical bleeding. The purpose of this study is to evaluate the effectiveness of no treatment versus empiric treatment with a single dose of cefixime and azithromycin for cure of MPC. Empiric treatment is the initiation of treatment prior to a firm diagnosis. Study participants will include 772 women ages 18 and older in good health with MPC. Women will be randomly assigned to 1 of 2 possible study groups: Group 1 will receive a single dose of cefixime and azithromycin antibiotics and Group 2 will receive placebo (inactive substance). Study procedures will include pelvic examination with a cervical swab sample. Participants will be involved in study related procedures for approximately 2 months, which includes 3 study visits.

Conditions

  • Vaginitis Bacterial
  • Cervicitis

Interventions

OTHER

Placebo

Capsule will be filled with lactose and be identical in appearance to the capsule with the active ingredient.

DRUG

Azithromycin

Single dose will consist of 2 over-encapsulated capsules (500 mg each) administered orally.

DRUG

Cefixime

Single dose will consist of 1 over-encapsulated capsule (400 mg) administered orally.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-09-30
Completion
2011-12-31

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 NCT01072136 on ClinicalTrials.gov