Vonoprazan High-Dose Dual VS Levofloxacin Concomitant

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.

Group B :levofloxacin concomitant:

levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for 14 days.

Outcomes:

Primary: [Eradication rate / healing rate] assessed at [4-8 weeks post-treatment].

Secondary: Incidence of adverse events (mild, moderate, severe), treatment adherence (pill count or diary), and [other outcomes like symptom improvement or cost-effectiveness].

Sample Size: [N] participants per group to achieve [80-90%] power with alpha = 0.05.

Statistical Analysis: Intention-to-treat and per-protocol analyses. Categorical variables compared using chi-square or Fisher's exact test; continuous variables using t-test or Mann-Whitney U test. A p-value < 0.05 is considered statistically significant.

Inclusion criteria

• 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

Exclusion criteria

• 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