Advertisement

Topics

Empiric Therapy of Mucopurulent Cervicitis (MPC)

2014-08-27 03:15:48 | BioPortfolio

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.

Description

Mucopurulent cervicitis (MPC) is a clinical syndrome characterized by the presence of mucopurulent discharge from the cervix and other signs of inflammation such as easily induced cervical bleeding. This phase III study is designed to evaluate the effectiveness of no treatment (placebo) versus empiric treatment with a single dose of cefixime 400 mg and azithromycin 1 gram for clinical cure of MPC at 2 months of follow-up. Secondary aims of the study are: to compare the pelvic inflammatory disease (PID) rate and adverse event rates between no treatment (placebo) versus empiric treatment; explore the role of bacterial vaginosis and Mycoplasma genitalium in the persistence of MPC; evaluate microbiological cure rate of M. genitalium in women treated with cefixime and azithromycin versus placebo; and present the clinical cure, partial response and failure proportions at 2-3 weeks and 2 months for each study arm. Participants will include 772 women greater than or equal to 18 years of age from Sexually Transmitted Disease (STD) or Family Planning (FP) clinics in good general health with MPC in New Orleans, LA; Birmingham, AL; Jackson, MS; Los Angeles, CA; and an additional site to be determined. Research specimens will be obtained at the time of the pelvic examination. As part of the study protocol, 3 cervical and 4 vaginal swabs will be collected at screening, follow-up visit 1, and follow-up visit 2. Eligible participants with clinical MPC at the time of their pelvic examination (cervical mucopus or easily induced cervical bleeding), will be consented, screened, enrolled, and randomized to one of the following arms: Group 1: empiric treatment: a single dose of cefixime 400 mg (1 capsule oral at 400 mg) and azithromycin 1 gm (2 capsules oral at 500 mg each) or Group 2: no treatment: placebo pills that look identical to the above medications. Subjects will be involved in study related procedures for 2 months.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

C. Trachomatis

Intervention

Azithromycin, Cefixime, Placebo

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35294-0007

Status

Recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:48-0400

Clinical Trials [235 Associated Clinical Trials listed on BioPortfolio]

Cefixime / Azithromycin pK Study

This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, b...

Partnership for Rapid Elimination of Trachoma

Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to ...

Randomized, Open-label, Multicenter Study of Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection

Chlamydia trachomatis is the most commonly reported bacterial sexually transmitted infection (STI), especially among young women. Up to 75% of C. trachomatis infected women are asymptomati...

Randomized, Double-Blinded, Placebo-Controlled Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM

A Phase 4 trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who hav...

NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube...

PubMed Articles [969 Associated PubMed Articles listed on BioPortfolio]

Determining the in vitro susceptibility of Neisseria gonorrhoeae isolates from 8 cities in Guangdong Province through an improved microdilution method.

A microdilution method for the antibiotic susceptibility testing of Neisseria gonorrhoeae was established and improved, and the antibiotic resistance of N. gonorrhoeae samples isolated from 8 cities o...

A Longitudinal Analysis of Chlamydial Infection and Trachomatous Inflammation Following Mass Azithromycin Distribution.

Mass azithromycin distributions are effective for clearing ocular strains of Chlamydia trachomatis, yet infection frequently returns in areas with hyperendemic trachoma. A better understanding of the ...

Surface plasmon resonance of gold nanoparticles as a colorimetric sensor for indirect detection of Cefixime.

This study reports a colorimetric sensor with excellent sensitivity to detect Cefixime base on gold nanoparticles. Cefixime is an antibiotic which has a wide range of applications in medicine. Cefixim...

Antimicrobial resistance following mass azithromycin distribution for trachoma: a systematic review.

Mass azithromycin distribution is a core component of trachoma control programmes and could reduce mortality in children younger than 5 years in some settings. In this systematic review we synthesise ...

Antimicrobial resistance and molecular characteristics of Neisseria gonorrhoeae isolates from MSM.

To analyze the susceptibility of Neisseria gonorrhoeae isolates to penicillin (Pen), cefixime (Cfm), ceftriaxone (Cro), tetracycline (Tet), ciprofloxacin (Cip), azithromycin (Azm) and spectinomycin (S...

Medical and Biotech [MESH] Definitions

A third-generation cephalosporin antibiotic that is stable to hydrolysis by beta-lactamases.

A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A chronic infection of the CONJUNCTIVA and CORNEA caused by CHLAMYDIA TRACHOMATIS.

More From BioPortfolio on "Empiric Therapy of Mucopurulent Cervicitis (MPC)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial