Efficacy of Levofloxacin-Doxycycline Based Rescue Therapy for Helicobacter Pylori Eradication: A Prospective Open-label Trial in Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Eradication rate of second line levofloxacin- doxycycline based therapy for H. pylori eradication after failed fisrt line therapy using Urea Breath Test and its association with symptoms resolution.
研究概览
简要总结
Helicobacter pylori (H. pylori) eradication is achieved in 60-80% with first-line therapy. Different second-line therapeutic options are available. However, the success of second-line therapy has not been addressed or reported from Saudi Arabia.
Objectives The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment.
详细描述
A prospective, open-label, single arm study was conducted. Patients were recruited from a tertiary care hospital in Saudi Arabia from June 2013 to April 2014. A total of 55 patients had previously received standard triple therapy and/or sequential therapy in the period from 2011 to 2014 and failed to eradicate the infection. The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily. Urea-breath-test (UBT) was done at a minimum of 6 weeks after completion of the treatment to confirm the H. pylori eradication. Compliance and tolerability of the regimen were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •18 years of age or older
- •Received previous treatment with triple therapy, sequential therapy or both
- •Has evidence of persistence H. pylori infection by a positive urea breath test (UBT), histology or rapid urease test (HP Fast. GI supply™, PA, USA)
排除标准
- •Previously treated with quadruple or levofloxacin-based therapy
- •Had an allergy to doxycycline, levofloxacin or esomeprazole
- •Pregnant or lactating
- •Significant hepatic, renal, or cardiopulmonary disorders, or active malignancy.
研究组 & 干预措施
Levofloxacin and Doxycycline and Esomeprazole
The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily
干预措施: Levofloxacin (Drug)
Levofloxacin and Doxycycline and Esomeprazole
The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily
干预措施: Doxycycline (Drug)
Levofloxacin and Doxycycline and Esomeprazole
The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Eradication rate of second line levofloxacin- doxycycline based therapy for H. pylori eradication after failed fisrt line therapy using Urea Breath Test and its association with symptoms resolution.
时间窗: 6 weeks
The primary endpoint was a negative UBT after a minimum of 6 weeks after completion of treatment
次要结局
- Symptoms response to treatment(6 weeks)
- Factors associated with eradication of H.pylori(6 weeks)
- Adverse events associated with the treatment(6 weeks)
研究者
Fahad Alsohaibani
Consultant, Hepatology/Gastroenterology
King Faisal Specialist Hospital & Research Center