Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

Inclusion Criteria:

- Subject is a male or female 15 years of age or older.

- Subject must have had 1 or more of the following occur:

1. gonorrhea with the nucleic acid amplification test (NAAT) or culture within the
previous 14 days

2. unprotected genital contact within 14 days with a person confirmed to be infected
with gonorrhea,

3. gram-negative present in urogenital gram strain or male subject must present with
purulent urethritis or a female subject with must present with mucopurulent
cervical discharge

- Subject agrees to avoid unprotected sexual contact in order to minimize the risk of
gonorrhea reinfection

- Subject must be in good health (ie, based on medical history), as determined by the
investigator.

- In the opinion of the investigator, the subject must be able and willing to comply
with protocol requirements. The subject must agree to provide reliable, verifiable
contact information and agree to return for the Test-of-Cure Visit.

- If a subject's age is 15 years to less than the legal age of consent,a written,
voluntarily signed assent must be obtained from the subject and a written, voluntarily
signed informed consent must be signed by the subject's parent or legal guardian
before the initiation of any study related procedures, unless the Institutional Review
Board (IRB)/Independent Ethics Committee (IEC) determines that parent/legal guardian
consent is not required.

Exclusion Criteria:

- Confirmed, or suspected, complicated or systemic gonococcal infection, such as pelvic
inflammatory disease, arthritis, or endocarditis.

- Subject has taken one of the following products within 6 hours of the Entry Visit that
may interfere with the absorption of a quinolone antibiotic: magnesium/aluminum
antacids; sucralfate; Videx® (didanosine) chewable/buffered tablets; other highly
buffered drugs; or other products containing calcium, iron, or zinc.

- Use of systemic or intravaginal antibiotics that are potentially effective against
gonorrhea 4 weeks prior to study drug administration.

- Subjects with a current or prior history of seizures, and subjects being treated with
drugs that are known to have a sizable potential of or reduce the threshold for
inducing seizures (eg, bupropion, theophylline, and tricyclic and tetracyclic
antidepressants).

- Current use of systemic corticosteroid or immunosuppressive drugs.

- Known significant immunosuppression (eg, cluster of differentiation (CD4) cell count
<200/mm3 or absolute neutrophil count <500/mL).

- Cytotoxic chemotherapy or radiation therapy during the previous 3 months.

- Subject is co-infected with an additional sexually transmitted disease (STD) for which
treatment cannot be safely deferred until after the Test-of-Cure Visit unless the
treatment is not potentially effective against gonorrhea.

- Subject has used an investigational drug or product within 30 days before study drug
dosing.

- Medical history of Type 1 hypersensitivity to antibiotics of the quinolone or
cephalosporin classes.

- Hysterectomized subjects without a cervix are ineligible.