Vonoprazan High-Dose Dual VS Levofloxacin Concomitant
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDamascus Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Vonoprazan
- Levofloxacin 500mg
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov