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临床试验/2024-517508-12-00
2024-517508-12-00招募中4 期

Infections after hysterectomy - a placebo controlled study comparing the profylactic use of azithromycin and cefuroxime with single cefuroxime

HUS-Yhtymae6 个研究点 分布在 1 个国家目标入组 2,278 人开始时间: 2024年10月24日最近更新:
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
2,278
试验地点
6
主要终点
Deep wound and pelvic organ infections up to 30 days postoperatively

研究概览

简要总结

To study post-hysterectomy infections and to compare the use of azithromycin and cefuroxime vs single cefuroxime in antibiotic prophylaxis

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing hysterectomy for a benign indication in a public hospital in Finland who have not any contraindications for azithromycin or cefuroxime. The person must understand the information given in finnish or swedish.

排除标准

  • Inability to understand the study protocol. Allergy for either cefuroxime or azithromycin. Congenital or acquired prolonged QTc interval. Use of medicines that may prolong QTc interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilidi, amiodarone and sotalol). Use of SSRI medication and prolonged QTc interval.

结局指标

主要结局

Deep wound and pelvic organ infections up to 30 days postoperatively

Deep wound and pelvic organ infections up to 30 days postoperatively

次要结局

  • Surficial infections and other infections, such has urine tract infections, and fever over 38 ℃ over 2 days.

研究者

发起方
HUS-Yhtymae
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

HUS Naistenklinikka

Scientific

HUS-Yhtymae

研究点 (6)

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