Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Evaluation of the Single-dose Efficacy of Oral Delafloxacin Versus the Single-dose Efficacy of an Intramuscular Injection of Ceftriaxone in Subjects With Uncomplicated Urogenital Gonorrhea

Conditions
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Gonorrhea

Intervention / Treatment
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* Drug: Delafloxacin
* Drug: Ceftriaxone


Participation Criteria
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Eligibility Criteria
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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: gonorrhea with the nucleic acid amplification test (NAAT) or culture within the previous 14 days unprotected genital contact within 14 days with a person confirmed to be infected with gonorrhea, 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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delafloxacin<br>900mg orally (2 x 450 mg tablets) administered once | Drug: Delafloxacin<br>* single dose<br>|
| Active Comparator: ceftriaxone<br>Ceftriaxone 250 mg intramuscular injection administered once | Drug: Ceftriaxone<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC. | Day 7 (± 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Cure for the seconday outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC. | Day 7 (± 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-Infective Agents, Gonorrhea, N. gonorrhoeae, bacterial infection, Anti-Bacterial Agents