NCT03959527已完成3 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
Global Antibiotics Research and Development Partnership17 个研究点 分布在 5 个国家目标入组 1,011 人开始时间: 2019年11月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,011
- 试验地点
- 17
- 主要终点
- Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.
研究概览
简要总结
This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and Ethics guidance)
- •Weight ≥ 35 kg
- •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 test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture)
- •For females of child-bearing potential, a negative urine pregnancy test at screening
- •For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study.
- •For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment
- •Willingness to comply with trial protocol
- •Willingness to undergo HIV testing
- •Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex until end of trial visit
- •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).
排除标准
- •Confirmed or suspected complicated or disseminated gonorrhoea
- •Pregnant or breastfeeding women
- •Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)
- •Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening
- •Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening
- •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
- •Cytotoxic or radiation therapy within 30 days prior to screening
- •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
- •History of urogenital sex-reassignment surgery
- •Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count <200 cells/μL
- •Know clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation
- •Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics
- •Known or suspected allergies or hypersensitivities to lidocaine, methylparaben, lactose or any of the components of the study drugs (refer to the zoliflodacin IB and SmPC for the comparators treatments)
- •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
- •History of alcohol or drug abuse within 12 months prior to screening which would compromise trial participation in the judgment of the investigator
- •Severe medical or psychiatric condition which, 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
- •Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol
- •Previous randomisation in this clinical trial.
- •Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of the drug, whichever is greater, prior to screening
研究组 & 干预措施
zoliflodacin
Experimental
Participant in this arm will receive a single dose of zoliflodacin.
干预措施: zoliflodacin (Drug)
ceftriaxone and azithromycin combination
Active Comparator
Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).
干预措施: ceftriaxone (Drug)
ceftriaxone and azithromycin combination
Active Comparator
Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).
干预措施: azithromycin (Drug)
结局指标
主要结局
Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.
时间窗: Day 6 (+/- 2)
Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at test of cure visit in micro-ITT (urogenital) analysis set
次要结局
- Safety of a Single Dose of Zoliflodacin Will be Assessed Compared to a Combination a Single Dose of Ceftriaxone and Azithromycin.(Day 30)
- Microbiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.(Day 6)
- Microbiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.(Day 6)
- The Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.(Day 6)
- Microbiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin(Day 6)
- Microbiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin(Day 6)
- Eradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.(Day 6)
- Eradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.(Day 6)
- Eradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.(Day 6)
- Arithmetic Mean Plasma Concentration of Zoliflodacin(24 - 36 h)
- Evaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin(Day 2)
- Evaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin(Day 2)
- Evaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin(Day 2)
- Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin(Day 2)
- Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)(Day 1)
- Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.(Day 6)
- Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline(Day 1)
- Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.(Day 6)
- Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline(Day 1)
- Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.(Day 6)
- Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline(Day 1)
- Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit(Day 6)
- Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline(Day 1)
- Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.(Day 6)
- Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline(Day 1)
- Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit(Day 6)
- Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline(Day 1)
- Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit(Day 6)
- Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline(Day 1)
- Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit(Day 6)
研究者
研究点 (17)
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