Gonorrhea
Conditions
Keywords
Gonorrhea, N. gonorrhoeae, bacterial infection, Anti-Infective Agents, Anti-Bacterial Agents
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.
Interventions
DRUGDelafloxacin
single dose
DRUGCeftriaxone
single dose
Sponsors
Melinta Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Day 7 (± 3 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Day 7 (± 3 days) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Delafloxacin 900mg orally (2 x 450 mg tablets) administered once
Delafloxacin: single dose | 304 |
| Ceftriaxone Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone: single dose | 154 |
| Total | 458 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Did not take study drug | 2 | 0 |
| Overall Study | Lost to Follow-up | 3 | 5 |
Baseline characteristics
| Characteristic | Delafloxacin | Ceftriaxone | Total |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 8.82 | 28.7 years STANDARD_DEVIATION 10.04 | 29.3 years STANDARD_DEVIATION 9.25 |
| Age, Customized 18-70 years | 303 Participants | 152 Participants | 455 Participants |
| Age, Customized <18 year | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 22 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 268 Participants | 131 Participants | 399 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Positive culture for Gonorrhea (GC) | 239 Participants | 107 Participants | 346 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 186 Participants | 92 Participants | 278 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 13 Participants | 25 Participants |
| Race (NIH/OMB) White | 98 Participants | 48 Participants | 146 Participants |
| Sex: Female, Male Female | 59 Participants | 35 Participants | 94 Participants |
| Sex: Female, Male Male | 245 Participants | 119 Participants | 364 Participants |
| Sex/Gender, Customized Men who: Had sex with men or were bisexual | 112 Participants | 60 Participants | 172 Participants |
| Sex/Gender, Customized Men who: Missing | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Men who: Were heterosexul | 132 Participants | 59 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 304 | 0 / 154 |
| other Total, other adverse events | 121 / 304 | 13 / 154 |
| serious Total, serious adverse events | 0 / 304 | 1 / 154 |
Outcome results
Primary
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.
Time frame: Day 7 (± 3 days)
Population: The primary efficacy analysis was done on the UMITT population, which included all subjects in the ITT analysis set who had a positive culture for N gonorrhoeae obtained at a urogenital site at the Entry Visit, and who did not receive antibiotic therapy for a C trachomatis infection that was potentially effective against N gonorrhoeae prior to TOC.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Delafloxacin | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Cure | 194 Participants |
| Delafloxacin | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Failure | 34 Participants |
| Ceftriaxone | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Cure | 91 Participants |
| Ceftriaxone | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Failure | 9 Participants |
95% CI: [-13.18, 1.36]
Secondary
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.
Time frame: Day 7 (± 3 days)
Population: Urogenital ME (UME): All subjects included in the UMITT analysis set who received study drug and had no important protocol deviations that would affect the assessment of efficacy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Delafloxacin | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Cure | 194 Participants |
| Delafloxacin | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Failure | 32 Participants |
| Ceftriaxone | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Cure | 91 Participants |
| Ceftriaxone | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Failure | 4 Participants |
95% CI: [-16.03, -3.87]