Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae

Inclusion Criteria

• Willing and able to give voluntary written informed consent before any study related procedure is performed.
• 18 years or older, on the day of enrollment.
• Untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.

*Subjects must have gyrA serine 91 genotype detected for N. gonorrhoeae from at least one non-pharyngeal site.

• Willing to abstain from sexual intercourse or use condoms during any sexual contact until the Test of Cure Visit (Visit 2, Day 5-10) is complete.
• Women of childbearing potential must have no vaginal intercourse 14 days before enrollment or use an effective birth control method for 30 days before enrollment and agree to continue through visit 2.

*A woman is considered of childbearing potential unless post-menopausal (greater than 2 years) or surgically sterilized (tubal ligation greater than 1 year, bilateral oophorectomy, or hysterectomy).

**Acceptable birth control methods for the purposes of this study may include abstinence from intercourse with a male partner, monogamous relationship with vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, and licensed hormonal methods. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly.

• Able to swallow pills.
• Willing to comply with protocol requirements, including availability for follow-up for the duration of the study.
• Agree to avoid systemic or intravaginal antibiotics with activity against N. gonorrhoeae from enrollment through Visit 2 (Day 5-10). Topical and intravaginal antifungals are permitted.
• Agree to avoid magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, up to 2 hours after receipt of study drug.

Exclusion Criteria

• Known renal insufficiency from clinical history.
• Use of systemic or intravaginal antibiotics with potential activity against N. gonorrhoeae within 30 days prior to study drug administration.

*Topical and intravaginal antifungals are permitted.

• Use of systemic corticosteroid drugs or other immunosuppressive therapy within 30 days prior to enrollment.
• Receipt or planned receipt of an investigational product in a clinical trial within 30 days prior to or 7 days after treatment administration.
• Pregnant or breastfeeding.
• Clinical diagnosis of pelvic inflammatory disease or genital ulcer.
• Confirmed or suspected complicated or systemic gonococcal infection, such as abdominal pain, testicular pain, epididymitis, orchitis, arthritis, or endocarditis.
• Receipt of magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, within 6 hours before receipt of study drug.
• Mutant N. gonorrhoeae gyrA serine 91 genotype from any anatomic site, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.
• Known allergy or history of adverse reaction to ciprofloxacin.
• Known allergy to quinolones.
• Previous enrollment in this study.
• Medical condition or other factor that in the judgment of the investigator might affect ability to comply with procedures.