Vonoprazan High-Dose Dual VS Levofloxacin Concomitant

Efficacy and Safety of Vonoprazan High-Dose Dual Therapy Compared to Levofloxacin Concomitant Therapy for H. Pylori Eradication: A Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastritis; Helicobacter Pylori Infection; Peptic Ulcer Disease
• Intervention / Treatment: Drug: Vonoprazan; Drug: Levofloxacin 500mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Syria
  • Damascus, Syria
    • General Assembly of Damascus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vonoprazan High-Dose Dual; Participants receive vonoprazan 20 mg twice daily (BID) plus amoxicillin 1 g three times daily (TID) for 14 days. Vonoprazan is taken before meals. Amoxicillin is taken at evenly spaced intervals (approximately every 8 hours).	Drug: Vonoprazan; 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.; Other Names: PPI; Amoxicillin
Experimental: levofloxacin concomitant; (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks).	Drug: Levofloxacin 500mg; 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; Other Names: Amoxicilline; Tinidazole; Esomperazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two weeks/14 days

Collaborators and Investigators

• Sponsor: Damascus Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Vonoprazan; Helicobacter Pylori Infection
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Duodenal Diseases; Gastritis; Peptic Ulcer; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Amides; Penicillin G; beta-Lactams; Lactams; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ofloxacin; Nitroimidazoles; Nitro Compounds; Ampicillin; Penicillins; Amoxicillin; Levofloxacin; Tinidazole; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
• Other Study ID Numbers: D202660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD underlying published results will be shared upon reasonable request to the corresponding author, subject to a signed data access agreement.
• IPD Sharing Time Frame: after ending RCT
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No