Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
Condition: Gonorrhea
MeSH terms: Gonorrhea
Intervention: Delafloxacin; Ceftriaxone
Intervention description: single dose; single dose
Intervention MeSH terms: Ceftriaxone; Delafloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 460.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Gonorrhea; N. gonorrhoeae; bacterial infection; Anti-Infective Agents; Anti-Bacterial Agents

Summary:

      The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin
      versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated
      cervical, urethral, rectal, or pharyngeal gonorrhea.
    

Eligibility criteria:

        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.