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临床试验/NCT05216744
NCT05216744已完成2 期

Comparison of Efficacy of Two Combination Regimens for the Treatment of Uncomplicated Neisseria Gonorrhoeae and Chlamydia Trachomatis Coinfection

Haiphong University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2021年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
125
试验地点
1
主要终点
cure rate

研究概览

简要总结

The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates.Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.

详细描述

Gonococcal infections, including urethritis, cervicitis, epididymitis, and proctitis, are a significant cause of morbidity among sexually active men and women. The treatment of these sexually transmitted infections (STIs) has evolved over the years, mainly due to the emergence of antibiotic resistance. The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates. Ceftriaxone is highly effective against susceptible N. gonorrhoeae. Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. These doses of ceftriaxone are higher than previously recommended due to concerns regarding rising gonococcal minimum inhibitory concentrations (MICs) worldwide. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline (100 mg orally twice daily for seven days) was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.

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

入选标准

  • Patient over 18 ages with laboratory-documented uncomplicated Chlamydia trachomatis and Neisseria gonorrhoeae reinfection at any site

排除标准

  • Pregnancy
  • Breast feeding
  • Hypersensitivity to cephalosporins or penicillins
  • significant renal failure or hepatic failure

研究组 & 干预措施

Doxycycline plus ceftriaxone

Experimental

Each subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously

干预措施: Ceftriaxone 1000mg + doxycycline 100 mg (Drug)

Doxycycline plus cefixime

Active Comparator

Each subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg

干预措施: Cefixime 800mg + doxycycline 100 mg (Drug)

结局指标

主要结局

cure rate

时间窗: 5th day after treatment

a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae

次要结局

  • Side effects(From 1st day of study to 5th day after treatment)

研究者

发起方
Haiphong University of Medicine and Pharmacy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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