A multi-center, randomized, open-labe, noninferiority trial to evaluate the efficacy and safety of a single, oral dose of Zoliflodacin compared to a combination of a single intramuscular dose of Ceftriaxone and a single oral dose of Azithromycin in the treatment of patients with uncomplicated gonorrhoea.
- Conditions
- GonorrhoeaNeisseria gonorrhoeae10004018
- Registration Number
- NL-OMON54942
- Lead Sponsor
- Institution Global Antibiotics Research and Development Partnership (GARDP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
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)
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 (<=1 month) CD4 count below 200
cells/microliter (µL)
11. Known clinically relevant cardiac pro-arrhythmic conditions such ascardiac
arrhythmia, congenital or documented QT prolongation
12. Known history of severe allergy to cephalosporin, penicillin, monobactams,
carbapenems or macrolide antibiotics
13. Known or suspected allergies or hypersensitivities to lidocaine,
methylparaben, lactose or any of the components of the study drugs (refer to
the zoliflodacin investigator brochure (IB) and ummaries of product
characteristics (SmPC) for the comparator treatments)
14. Receipt or planned receipt of an investigational product in a clinical
trial within 30 days or five half-lives of the drug, whichever is greater prior
to screening until end of participation to this clinical trial
15. History of alcohol or drug abuse in the 12 months prior to screening which
would compromise trial participation in the judgement of the investigator
16. Severe medical or psychiatric condition that, in the opinion of the
investigator, may increase the risk associated with trial participation or may
interfere with the interpretation of trial results or affect the individual's
ability to provide informed consent
17. Individuals whom, in the judgement of the investigator, are unlikely or
unable to comply with this trial protocol
18. Previous randomisation in this clinical trial
19. Use of moderate or strong CYP3A4 inhibitors within 30 days or five
half-lives of the drug, whichever is greater, prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Microbiological cure as determined by culture at urethral or cervical sites at<br /><br>TOC (day 6 ±2)</p><br>
- Secondary Outcome Measures
Name Time Method