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NCT07624422
Vonoprazan High-Dose Dual VS Levofloxacin Concomitant
Conditions: Helicobacter Pylori Infection, Peptic Ulcer Disease, Gastritis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 150
Sponsor: Damascus Hospital
Location: General Assembly of Damascus Hospital Damascus
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07624422). StuddyBuddy aggregates publicly available trial information.
