Empiric Therapy of Mucopurulent Cervicitis (MPC)

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.