2025-524475-23-00招募中3 期
Efficacy of Temocillin compared to standard of care in the Treatment of Neisseria gonorrhoeae Infections: A Multicenter Randomized Controlled Non-Inferiority Trial (TEMtoGo).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 7
研究概览
简要总结
Demonstrate the non-inferiority of 2g IV or IM temocillin treatment compared to the reference treatment with 1g IM ceftriaxone (Standard of Care (SOC)) for Neisseria gonorrhoeae infections at D21 (negative PCR in urine/vagina, throat and/or anus).
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase III
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •1- Age ≥ 18 years
- •2- Positive PCR for Ng (urine/vagina and/or throat and/or anus)
- •3-Asymptomatic Neisseria gonorrhoeae infection
- •4- Patient who has understood the entirety of the study and accepts its constraints
- •5-Women of child-bearing potential (i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile) who are sexually active have to apply a effective method of birth control, throughout the study period and for 90 days following the last dose of study treatment.
- •6- Signature of the consent form for participation in the trial.
- •7- Affiliation with a Social Security scheme or State Medical Aid (AME) (waiver to exempt the necessity for patients to be affiliated with a such scheme)
- •8- French, English or Spanish speaker
排除标准
- •1 - Known allergy to penicillin, temocillin, ceftriaxone or other beta-lactam antibiotics (grade 3 or 4), or lidocaine
- •10 -Known renal or hepatic dysfunction
- •11 - Patient on curative anticoagulation or known hemostasis disorder (contraindication for the IM route)
- •12 - Prior participation in this study
- •13 - Patient under legal guardianship
- •14 - Participation in another randomized trial or trial concerning a medicinal product or clinical investigation protocol concerning a medical device (<3 months)
- •15- patients deprived of liberty by judicial or administrative decision
- •16- Patients who are the investigator or any other member of the study team, or close relatives of the investigator or persons involved in the study (e.g., assistant physicians, pharmacists, nurses…)
- •2- Known complete heart block
- •3- Known hypersensitivity to lidocaine or other amide-type anesthetics
- •4- Clinical suspicion of hypovolemia
- •5 - Concomitant antibiotic treatment to be started or in progress for another bacterial infection except for doxycycline as post exposure prophylaxis
- •6 - BMI> 35 kg/m2
- •7 - Another ongoing antibiotic therapy < 1 month except for doxycycline as post exposure prophylaxis
- •8- Complicated upper genital infection
- •9 - Pregnant or breastfeeding woman (urinary βHCG at baseline)
研究者
Dr Laure SURGERS
Scientific
Assistance Publique Hopitaux De Paris
研究点 (7)
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