Table 2.

Inclusion and exclusion criteria for human challenge experiment

Inclusion criteria

Healthy man ≥18 and ≤36 years old Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number) Willingness to provide written informed consent Able and willing to attend all study visits Able and willing to abstain from all sexual activity until completion of study and follow- up test for gonorrhea is negative Acceptable medical history by screening evaluation No clinically significant abnormalities on physical exam Urinalysis: leukocyte esterase value and white blood cell count within normal limits Total complement (CH50) value within normal limits Urine negative for chlamydia, gonorrhea, and Trichomonas Negative HIV, syphilis, and HCV serologic test results Negative HBV core and surface antibodies or results consistent with immunization (negative HBV core antibody/positive HBV surface antibody) Denies history of sexually transmitted infections including gonorrhea, chlamydia, syphilis, HIV, HBV, and HCV Denies history of bleeding diathesis Denies history of seizures (due to reports of seizures with ciprofloxacin) Denies history of cancer, except basal cell carcinoma of the skin >5 years ago Denies history of drug abuse Denies history of genitourinary surgery

Exclusion Criteria

Student or employee under the direct supervision of any of the study investigators Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease, or HIV infection Psychiatric disorders that could interfere with the integrity of the data or subject safety Unstable depression or depression that could compromise the subject’s ability to comply with protocol requirements Heart murmur or heart disease Anatomic abnormality of the urinary tract Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days Self-reported chemotherapy within the past year Current steroid use, except for topical application Allergy to penicillin, cephalosporins or ciprofloxacin or to lidocaine Treatment with medications in the previous month that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the doses given in the study Serum creatinine level <0.7 or >1.75 mg/dL Serum alanine aminotransferase (ALT) level <lower limit of normal or >105 U/L White blood cell count <2.5 or >15.0 × 109/L Absolute neutrophil count (ANC) <1.5 or >7.5 × 109/L and deemed clinically significant by the study physician. For African Americans, ANC values as low as 1.3 × 109/L are allowed Hemoglobin level <12.0 g/dL or above upper limit of normal Urinalysis: Qualitative protein level >1+ or red blood cell count >10/high powered field