跳至主要内容
临床试验/NCT04902560
NCT04902560已完成不适用

Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Response rate to Ceftriaxone 1g IM in Gonorrhoea.

研究概览

简要总结

Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.

Patients wanting STI screening can consult either they are symptomatic or not.

If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.

Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.

After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.

Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.

Compliance to current recommandation at CeGIDD Montpellier has never been evaluated.

This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Response rate to Ceftriaxone 1g IM in Gonorrhoea.

时间窗: day 1

Evaluated by a test of cure (TOC) which must be negative 15 days after the subject received the treatment (ceftriaxone).

次要结局

  • Adverse drug reaction rates(day 1)
  • Rate of untreated patient despite having a positive test for gonorrhea (lost to follow-up)(day 1)
  • Concordance rate with positive PCR(day 1)
  • Resistance rate to ceftriaxone and AMR description.(day 1)
  • Rate of time before realizing the TOC.(day 1)
  • Rate of realized TOC(day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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