Vonoprazan High-Dose Dual VS Levofloxacin Concomitant

ConditionsHelicobacter Pylori Infection Peptic Ulcer Disease Gastritis

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Vonoprazan
Drug
Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose adjustments permitted during the 14-day treatment period.
Levofloxacin 500mg
Drug
Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Vonoprazan High-Dose DualActive comparator 1 intervention

Group B: levofloxacin concomitantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

H. pylori Eradication Rate

Proportion of participants with negative H. pylori status confirmed by urea breath test (or stool antigen test) at least 4 weeks after completion of study treatment. Eradication is defined as a negative test result. Both intention-to-treat and per-protocol analyses will be performed.

Time frame

two weeks/14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Damascus Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: