Vonoprazan High-Dose Dual VS Levofloxacin Concomitant

NCT07624422 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: D202660
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peptic Ulcer Disease; Gastritis; Helicobacter Pylori Infection

Keywords

Helicobacter Pylori Infection; Vonoprazan

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vonoprazan High-Dose Dual

ACTIVE COMPARATOR

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

levofloxacin concomitant

EXPERIMENTAL

(levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks).

Drug: Levofloxacin 500mg

Interventions

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.

Also known as: Amoxicillin, PPI

Vonoprazan High-Dose Dual

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

Also known as: Tinidazole, Amoxicilline, Esomperazole

levofloxacin concomitant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus Hospital: lead

Study Sites (1)

General Assembly of Damascus Hospital

Damascus, Syria

Location

MeSH Terms

Conditions

Peptic Ulcer; Gastritis

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Levofloxacin; Tinidazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind. Only the outcome assessor is masked to treatment assignment. Participants and care providers are not blinded due to regimen differences.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: gastroenterologist

Model Details: Parallel-group, randomized, active-controlled, superiority trial. Eligible participants are randomly assigned in a 1:1 ratio to receive either vonoprazan high-dose dual therapy or vonoprazan triple therapy for 14 days.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after ending RCT

Locations

SY (1)