Efficacy and Safety of Vonoprazan High-Dose Dual Therapy Compared to Levofloxacin Concomitant Therapy for H. Pylori Eradication: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection).
Participants will be randomly assigned to receive either regimen for 14 days. The primary outcome is eradication rate , and secondary outcomes include adverse events and treatment adherence.
详细描述
Study Design: This is a prospective, parallel-group, randomized controlled trial.
Setting: multi-center conducted at Damascus hospital and Iben Al-Nfees Hospital
Participants: Adult patients aged [18-70] years with confirmed [condition, e.g., H. pylori infection by urea breath test or histology]. Exclusion criteria include prior [vonoprazan use / antibiotic allergy / pregnancy / significant comorbidity].
Interventions:
Group A (High-Dose Dual Therapy): Vonoprazan [20 mg BID] + [amoxicillin, 1000 mg three times for 14 days.
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
- Single (Outcomes Assessor)
盲法说明
Single-blind. Only the outcome assessor is masked to treatment assignment. Participants and care providers are not blinded due to regimen differences.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 80 years (adjust upper limit as needed)
- •Confirmed Helicobacter pylori infection by at least one of the following: positive urea breath test, rapid urease test, histopathology, or stool antigen test
- •Treatment-naïve for H. pylori (no prior eradication therapy) - OR - prior treatment failure (specify if rescue therapy)
- •Willing and able to provide written informed consent
- •Willing to adhere to the 14-day treatment regimen and follow-up visits
- •For women of childbearing potential: negative pregnancy test and agreement to use effective contraception during the treatment period
排除标准
- •History of allergy or hypersensitivity to vonoprazan, amoxicillin, clarithromycin, metronidazole, or any other penicillin/cephalosporin
- •Previous H. pylori eradication therapy (if study is for first-line treatment)
- •Active gastrointestinal bleeding or perforation
- •Severe liver disease (Child-Pugh class B or C) or severe renal impairment (eGFR < 30 mL/min/1.73m²)
- •Pregnancy or breastfeeding
- •Concurrent use of medications with significant drug-drug interactions (e.g., warfarin, phenytoin, digoxin, atazanavir, rilpivirine)
- •Malignancy or any life-threatening condition with life expectancy < 6 months
- •Participation in another interventional trial within 30 days prior to enrollment
- •Any condition that, in the investigator's opinion, precludes safe participation or adherence to the protocol
研究者
Marouf Alhalabi
gastroenterologist
Damascus Hospital