Empiric Therapy of Mucopurulent Cervicitis (MPC)

NCT01072136 | Terminated Phase 3 Results

• 1 other identifier: 07-0082
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

mucopurulent cervicitis, chlamydia, gonorrhea, women

Outcome Measures

Primary Outcomes (1)

• Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC).

  The proportion of participants who have cleared MPC by the second follow-up visit. Clinical cure is defined as: absence of cervical mucopus and absence of easily induced cervical bleeding and \< 30 white blood cells per oil immersion field on cervical gram stain.

  Visit 2 - 2 months (Day 50-70).

Secondary Outcomes (7)

• Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.

  At 2-3 week and 2 month (Day 50-70) follow-up.

• Examine Adverse Events in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.

  At 2-3 week and 2 month (Day 50-70) follow-up.

• Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC).

  At 2 month (Day 50-70) follow-up.

• Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC).

  At 2 month (Day 50-70) follow-up.

• Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo.

  At 2-3 weeks and 2 month (Day 50-70) follow-up.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo.

Other: Placebo

Azithromycin/Cefixime

EXPERIMENTAL

A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each).

Drug: Azithromycin; Drug: Cefixime

Interventions

Placebo OTHER

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

Placebo

Azithromycin DRUG

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

Azithromycin/Cefixime

Cefixime DRUG

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

Azithromycin/Cefixime

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women greater than or equal to 18 years old in Sexually Transmitted Disease (STD) clinics or Family Planning clinics.
• Presence of cervical mucopus and/or easily induced cervical bleeding on pelvic exam via endocervical swab.
• Greater than or equal to 30 white blood cells (WBCs) per high power field in the cervical Gram stain. (Note: the cervical Gram stains will be sent to a central lab for review. The results will not be available at the time of enrollment. Subjects who do not meet this criterion will be withdrawn from the study at the time the results are available).
• Willingness to provide written informed consent
• Willing to abstain from sexual intercourse or use condoms during the entire study (approximately 2 months).
• Willing to abstain from using vaginal products during the entire study (approximately 2 months).

You may not qualify if:

• Signs and symptoms of pelvic inflammatory disease, including cervical motion, uterine, or adnexal tenderness.
• History of pelvic inflammatory disease (PID), ectopic pregnancy or recurrent cervicitis (3 or more episodes in the prior year) or written documentation of recent cervicitis (within past 30 days).
• Gonorrhea or Chlamydia on nucleic acid amplification test (NAAT) at time of enrollment. (Participant testing positive for Neisseria gonorrhoeae (GC) or Chlamydia trachomatis (CT) on enrollment visit sample will be discontinued).
• Women with motile trichomonas on wet mount examination or positive trichomonas culture at time of enrollment.
• Women with symptomatic bacterial vaginosis (BV) (based on clinical Amsel criteria for BV and reported symptoms by participant, i.e. discharge, vaginal odor, etc).
• Use of vaginal products in past 48 hours (i.e. douching, use of vaginal medications or suppositories).
• History of chronic renal disease by verbal or documented history.
• Current use of probenecid.
• Nursing mothers.
• Colitis or coagulopathy as per patient self-report.
• Known allergy to cephalosporins, penicillin or macrolides by verbal or documented history.
• History of latex allergy.
• Use of systemic antibiotics (oral or intravenous), vaginal antibiotics, vaginal antifungal, or oral antifungal use within 30 days of study enrollment.
• Women who will require antibiotic treatment due to GC or CT in a sexual partner.
• Serious underlying conditions, including human immunodeficiency virus (HIV) or other primary or secondary immunosuppressive condition.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

University of Alabama Hospital - Infectious Diseases

Birmingham, Alabama, 35249-0001, United States

Location

Harbor UCLA Medical Center - OBGYN - General Gynecology and Women's Health

Torrance, California, 90502-2006, United States

Location

Louisiana Stte University - Health Sciences Center - Medicine

New Orleans, Louisiana, 70112-1349, United States

Location

University of Mississippi - Infectious Diseases

Jackson, Mississippi, 39216-4505, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Uterine Cervicitis; Chlamydia Infections; Gonorrhea

Interventions

Azithromycin; Cefixime

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases; Uterine Diseases; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Neisseriaceae Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study closed early due to slow accrual with 11% of the targeted sample size enrolled. Therefore, precision and power were low.

Results Point of Contact

• Title: Shelly Lensing
• Organization: University of Arkansas for Medical Sciences

sylensing@uams.edu

501-686-8203

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 24, 2014
• Results First Posted: October 25, 2012

Record last verified: 2012-01

Locations

US (4)