Combining anti‑ulcer medicines with levofloxacin and amoxicillin to clear H. pylori infection

Evaluating the Effectiveness of Anti- Ulcerants (Dexlansoprazole, Lansoprazole, and Vonoprazan) With Levofloxacin-based Triple Therapy for Helicobacter Pylori Eradication - A Three-arm Randomized Controlled Trial

This study will test whether giving adults one of three acid‑reducing drugs (Dexlansoprazole, Lansoprazole, or Vonoprazan) together with levofloxacin and amoxicillin for 14 days can clear H. pylori infection.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 942 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dow University of Health Sciences (Academic / other)
• Locations: 1 site (Karachi)
• Trial ID: NCT07344506 on ClinicalTrials.gov

What this trial studies

This is a three‑arm, open‑label, randomized trial that assigns adults with urea breath test–confirmed H. pylori infection to one of three treatment arms. Each arm receives levofloxacin 500 mg plus amoxicillin 1 g together with either dexlansoprazole 60 mg, lansoprazole 30 mg, or vonoprazan 20 mg for 14 days. Participants are followed for eradication outcomes after treatment to compare H. pylori clearance rates between the regimens. The trial targets a local patient population with high baseline antibiotic resistance and aims to identify which acid suppression backbone yields the highest eradication when paired with levofloxacin-based therapy.

Who should consider this trial

Good fit: Adults of either sex with H. pylori infection confirmed by urea breath test who are not currently on H. pylori therapy, not pregnant or breastfeeding, and without recent antibiotic use or known allergies to the study drugs are ideal candidates.

Not a fit: People who recently took antibiotics, have allergies to the study medications, are pregnant or lactating, have severe mental disability, or are already receiving H. pylori treatment are unlikely to be eligible or benefit from participation.

Why it matters

Potential benefit: If successful, the regimen could raise H. pylori eradication rates and lower future risks of peptic ulcer disease and gastric cancer in treated patients.

How similar studies have performed: Levofloxacin‑based regimens and vonoprazan‑containing therapies have shown improved eradication in some prior studies, but regional antibiotic resistance patterns make results variable.

Eligibility criteria

Inclusion Criteria:

Adult patients of both sexes, presenting to the out-patient departments of the participating healthcare centres, and diagnosed through a UBT to have H.Pylori infection by their physician will be eligible for enrolment in the study, but are currently not receiving any treatment for H.Pylori infection.

Exclusion Criteria:

1. Those who will not provide written consent for the study.
2. Patients with severe mental disability,
3. pregnant or lactating women,
4. those who are already on treatment for H.Pylori infection, and
5. those who have received any antibiotic within the last two weeks of enrolling in this study will be excluded.
6. Patients with known previous documented drug allergies for the current regime will be excluded from the trial

Where this trial is running

Karachi

• Sindh Institute of Advanced Endoscopy and Gastroenterology (SIAG), DUHS — Karachi, Pakistan (Recruiting)

Conditions H. Pylori Gastrointestinal Disease; H.Pylori Infection; H.Pylori Eradication Rate; Helicobacter pylori, Peptic ulcer disease, Combination Triple regime, Dexlansoprazole, Lansoprazole, Vonoprazan, Eradication therapy, Treatment Efficacy; Randomized Controlled Trial; Three Arm