Empiric Therapy of Mucopurulent Cervicitis (MPC)
Condition: Vaginitis Bacterial; Cervicitis
MeSH terms: Vaginosis, Bacterial; Vaginitis; Uterine Cervicitis
Intervention: Placebo; Azithromycin; Cefixime
Intervention description: Capsule will be filled with lactose and be identical in appearance to the capsule with the active ingredient.; Single dose will consist of 2 over-encapsulated capsules (500 mg each) administered orally.; Single dose will consist of 1 over-encapsulated capsule (400 mg) administered orally.
Intervention MeSH terms: Azithromycin; Cefixime
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mucopurulent cervicitis, chlamydia, gonorrhea, women

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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).

        Exclusion Criteria:

          -  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.

          -  Concomitant infection, which requires antimicrobial therapy (for example, urinary
             tract infection, sinusitis, skin and soft tissue infection, tooth abscess, etc.) or
             expected use of any antibiotic/antimicrobial therapy during the study.

          -  Menstruation at the time of screening visit. Women who are menstruating can be
             screened after cessation of bleeding.

          -  Active herpes outbreak at the time of enrollment determined by clinical observation.

          -  Suspected pregnancy or positive urine pregnancy test at screening or actively seeking
             pregnancy during study period.

          -  Any clinical adverse event, intercurrent illness, or other medical condition or
             situation as determined by the investigator that is present or occurs such that
             participation in the study would not be in the best interest of the participant.

          -  Previously enrolled in this study.

          -  Unable to follow the protocol (inc. inability to comply with the follow-up
             procedures).

          -  Failing to provide contact information.