EUCTR2019-000990-22-NL进行中（未招募）1 期
A MULTI-CENTER, RANDOMIZED, OPEN-LABEL, NON INFERIORITY 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
GARDP FOUNDATIO0 个研究点目标入组 1,092 人开始时间: 2019年11月20日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,092
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. = 15 years old
- •2. = 35 kilogram (kg)
- •3. Signs and symptoms consistent with urethral or cervical gonorrhoea
- •Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test in the past 14 days prior to screening
- •Unprotected sexual contact with an individual confirmed to be infected with N. gonorrhoeae in the past 14 days prior to screening (positive NAAT, Gram stain, methylene blue test 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 contraception (see Appendix 1) from at least 28 days prior to screening and until at least 28 days after
- •treatment. Females on oral contraceptives must also use a barrier contraception method during participation 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. Willingness to undergo HIV testing
- •9. Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex from enrolment until end of trial 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)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 992
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •11. Confirmed or suspected complicated or disseminated gonorrhoea
- •12. Pregnant or breastfeeding females
- •13. Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)
- •14. Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening
- •15. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening
- •16. Use of moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five half-lives of the drug, whichever is
- •greater, prior to screening
- •17. Cytotoxic or radiation therapy within 30 days prior to screening
- •18. 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
- •19. History of urogenital sex-reassignment surgery
- •20. Immunosuppression as evidence by medical history, clinical examination or a recent (=1 month) CD4 count below 200 cells/microliter (µL)
- •21. Known clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation
- •22. Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics
- •23. 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 summaries of product characteristics (SmPC) for the comparator treatments)
- •24. 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
- •25. History of alcohol or drug abuse in the 12 months prior to screening which would compromise trial participation in the judgement of the investigator
- •26. 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
- •27. Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol
- •28. Previous randomisation in this clinical trial.
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