Clinical trial NCT02015637: Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gonorrhea
Keywords: Gonorrhea
N. gonorrhoeae
bacterial infection
Anti-Infective Agents
Anti-Bacterial Agents
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 460
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population
timeFrame: Day 7 (± 3 days)
Secondary outcomes:
measure: Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population
timeFrame: Day 7 (± 3 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Melinta 304 Study
state: Alabama
city: Chula Vista
country: United States
facility: Melinta 304 Study Site
state: California
city: La Mesa
country: United States
facility: Melinta 304 Study Site
state: California
city: Los Angeles
country: United States
facility: Melinta 304 Study Site
state: California
city: San Francisco
country: United States
facility: Melinta 304 Study Site
state: California
city: Atlanta
country: United States
facility: Melinta 304 Study
state: Georgia
city: Decatur
country: United States
facility: Melinta 304 Study
state: Georgia
city: Indianapolis
country: United States
facility: Melinta 304 Study Site
state: Indiana
city: New Orleans
country: United States
facility: Melinta 304 Study Site
state: Louisiana
city: Omaha
country: United States
facility: Melinta 304 Study Site
state: Nebraska
city: Las Vegas
country: United States
facility: Melinta 304 Study Site
state: Nevada
city: Bronx
country: United States
facility: Melinta 304 Study Site
state: New York
city: Brooklyn
country: United States
facility: Melinta 304 Study Site
state: New York
city: Brooklyn
country: United States
facility: Melinta 304 Study
state: New York
city: New York
country: United States
facility: Melinta 304 Study Site
state: New York
city: Durham
country: United States
facility: Melinta 304 Study Site
state: North Carolina
city: Greensboro
country: United States
facility: Melinta 304 Study Site
state: North Carolina
city: Cleveland
country: United States
facility: Melinta 304 Study Site
state: Ohio
city: Columbus
country: United States
facility: Melinta 304 Study Site
state: Ohio
city: Portland
country: United States
facility: Melinta 304 Study Site
state: Oregon
city: Erie
country: United States
facility: Melinta 304 Study
state: Pennsylvania
city: Philadelphia
country: United States
facility: Melinta 304 Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Melinta 304 Study Site
state: Pennsylvania
city: Houston
country: United States
facility: Melinta 304 Study Site
state: Texas
city: Seattle
country: United States
facility: Melinta 304 Study Site
state: Washington
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Sue Cammarata, MD
role: STUDY_DIRECTOR
References:
citation: Hook EW 3rd, Golden MR, Taylor SN, Henry E, Tseng C, Workowski KA, Swerdlow J, Nenninger A, Cammarata S. Efficacy and Safety of Single-Dose Oral Delafloxacin Compared With Intramuscular Ceftriaxone for Uncomplicated Gonorrhea Treatment: An Open-Label, Noninferiority, Phase 3, Multicenter, Randomized Study. Sex Transm Dis. 2019 May;46(5):279-286. doi: 10.1097/OLQ.0000000000000971.