Gonorrhoea Neisseria gonorrhoeae
Conditions
Interventions
Reference treatment: Combination of a single dose ceftriaxone 500 mg IM,
dissolved in lidocaine 1% and a single oral 1 g dose of azithromycin
Studiemedication: Single oral 3 g dose of zoliflodacin gr
Sponsors
Institution Global Antibiotics Research and Development Partnership (GARDP)
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. >= 12 years old (if enrolment of minors is in agreement with local regulations and ethics guidance, for Dutch site 16 years and older will be maintained) 2. >= 35 kilogram (kg) 3. Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual confirmed to be infected with NG in the past 14 days prior to screening (positive NAAT, Gram stain, methylene blue/gentian violet stain or culture) 4. For females of child-bearing potential, a negative urine pregnancy test at screening 5.For females of child bearing potential, use of highly effective method of contraception at the time of IMP administration on Day 1 (see Appendix 1: contraception methods considered as highly effective and required duration) and until at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participatien in the study. 6. For males with a female partner of child-bearing age, willingness to delay conception during the trial and for 28 days after treatment 7. Willingness to comply with trial protocol 8. For participants in the PK sub-study: Willingness to undergo HIV testing 9. Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex from enrollment until end of trial (EOT) visit 10. Willingness and ability to give written informed consent or be consented by a legal representative, or provide assent and parental consent (for minors, as appropriate)
Exclusion criteria
Exclusion criteria: 1. Confirmed or suspected complicated or disseminated gonorrhoea 2. Pregnant or breastfeeding females 3. Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG 4. Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening 5. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening 6. Use of moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five halflives of the drug, whichever is greater, prior to screening 7. Cytotoxic or radiation therapy within 30 days prior to screening 8. Known chronic renal, hepatic, hematologic impairment or other condition interfering with the absorption, distribution or elimination of the drug, based on medical history and physical examination 9. History of urogenital sex-reassignment surgery 10. Immunosuppression as evidence by medical history, clinical examination or a recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbiological cure as determined by culture at urethral or cervical sites at TOC (day 6 ±2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints * Incidence, severity, causality, and seriousness of treatment-emergent adverse events and the evaluation of changes from baseline in safety laboratory test results and physical examinations * Proportion of participants with microbiological cure as determined by culture at pharyngeal sites at TOC (day 6 ±2) * Proportion of participants with microbiological cure as determined by culture at rectal sites at TOC (day 6 ±2) * Proportion of male participants with clinical cure at TOC (day 6 ±2) * Proportion of female and male participants respectively with microbiological cure as determined by culture at cervical or urethral site at TOC (day 6 ±2) * Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at TOC and for whom the baseline antimicrobial susceptibility profile indicated pre-existing resistance to antibiotics commonly used for NG treatment (including to ceftriaxone alone, to azithromycin alone, and to both) * Antimicrobial susceptibility profile of gonococcal strains isolated at baseline and at TOC (day 6 ±2) * Proportion of participants with a negative NG nucleic acid amplification test (NAAT) from urethral or cervical sites at TOC (day 6 ±2) * Proportion of participants with a negative NG NAAT from oropharyngeal sites at TOC (day 6 ±2) * Proportion of participants with a negative NG NAAT from rectal sites at TOC (day 6 ±2) | — |
Countries
Netherlands
Outcome results
None listed