CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication

NCT07344506 | Recruiting Phase 4 DMC

• 1 other identifier: IRB-3887
• Study Type: interventional
• Target: 942
• Locations: 1 country
• Sites: 1

Brief Summary

This study, titled CURE-H. Pylori, is a three-arm, parallel-group, open-label, randomized controlled trial designed to evaluate the effectiveness of Dexlansoprazole, Lansoprazole, and Vonoprazan in combination with Levofloxacin and Amoxicillin for Helicobacter pylori eradication. H. pylori infection is a significant health issue worldwide, with an estimated prevalence of 44% globally and around 60% in Pakistan, leading to gastritis, peptic ulcer disease, and increased risks of gastric cancer and mucosa-associated lymphoid tissue lymphoma. Despite the widespread use of PPI-based triple therapies, treatment efficacy has decreased due to increasing antibiotic resistance, especially to Clarithromycin and Metronidazole. This study aims to assess the eradication rate of H. pylori in patients receiving either Dexlansoprazole 60mg, Lansoprazole 30mg, or Vonoprazan 20mg, each combined with Levofloxacin 500mg and Amoxicillin 1g for 14 days. Participants will be randomized into three arms (314 participants per arm) and assessed for H. pylori eradication using a Urea Breath Test (UBT) at follow-up, which will serve as the primary endpoint. Secondary objectives include assessing symptom improvement using the Gastrointestinal Symptom Rating Scale (GSRS), measuring symptoms such as reflux, abdominal pain, indigestion, diarrhea, and constipation. The study will enroll adult patients diagnosed with H. pylori via UBT and who are not currently receiving treatment for the infection. The study will be conducted at healthcare centers in major cities across Pakistan, including Peshawar, Faisalabad, Rawalpindi, Multan, Lahore, Karachi, and Quetta, over a 12-month period. All participants will sign informed consent forms before enrollment, ensuring they understand the study's procedures and risks. Statistical analysis will be performed using SPSS version 26, with categorical variables analyzed using the Chi-square or Fisher's exact test and continuous variables using descriptive statistics. The primary outcome is the H. pylori eradication rate, and secondary outcomes include the improvement in gastrointestinal symptoms. This study is significant because it aims to compare three different PPI-based therapies in the context of H. pylori eradication in a high-resistance population, providing much-needed data for tailoring treatment strategies in regions with high antibiotic resistance like Pakistan. The results could enhance the effectiveness and cost-efficiency of treatment regimens for H. pylori, ultimately improving patient outcomes and reducing the burden of gastric diseases. Ethical approval has been obtained from the Institutional Review Board (IRB) of Dow University of Health Sciences, Karachi, and all procedures will adhere to the principles of human subjects protection. This study will provide valuable insights into the comparative efficacy of different proton pump inhibitors when combined with Levofloxacin-based triple therapy, potentially leading to more effective treatment options for H. pylori infections in Pakistan and similar regions. The total required sample size for this study is 942 participants, with a 20% expected dropout rate. Data collection will be conducted at baseline and six weeks post-treatment, with the aim of addressing the region-specific challenges in H. pylori treatment and contributing to the global knowledge on optimal therapeutic strategies for this infection. Additionally, the trial's findings may contribute to the broader understanding of how regional antibiotic resistance patterns affect treatment outcomes and help shape future guidelines for H. pylori management in endemic areas. This trial will also help assess the safety and tolerability of the different therapies, providing a comprehensive evaluation of both therapeutic efficacy and patient quality of life post-treatment.

Conditions

H. Pylori Gastrointestinal Disease; H.Pylori Infection; H.Pylori Eradication Rate

Keywords

Helicobacter pylori, Peptic ulcer disease, Combination Triple regime, Dexlansoprazole, Lansoprazole, Vonoprazan, Eradication therapy, Treatment Efficacy; Randomized Controlled Trial; Three Arm

Outcome Measures

Primary Outcomes (1)

• H. pylori Eradication

  The primary outcome is the eradication rate of H. pylori, measured by a negative Urea Breath Test (UBT) after the completion of the 14-day treatment regimen in each of the three arms. A successful eradication is defined as a negative UBT performed four weeks after completing the treatment. The eradication rate will be compared between the three arms: Dexlansoprazole + Levofloxacin-based triple therapy, Lansoprazole + Levofloxacin-based triple therapy, and Vonoprazan + Levofloxacin-based triple therapy.

  2 years

Secondary Outcomes (3)

• Gastrointestinal Symptom Improvement:

  2 years

• Adverse Events

  2 years

• Treatment Compliance

  2 years

Study Arms (3)

Arm 1: Dexlansoprazole + Levofloxacin-Based Triple Therapy

EXPERIMENTAL

Dexlansoprazole 60mg BD + Levofloxacin 500mg OD + Amoxicillin 1g BD (for 14 days)

Drug: Arm 1: Dexlansoprazole + Levofloxacin-Based Triple Therapy

Arm 2: Lansoprazole + Levofloxacin-Based Triple Therapy

EXPERIMENTAL

Lansoprazole 30mg BD + Levofloxacin 500mg OD + Amoxicillin 1g BD (for 14 days)

Drug: Arm 2: Lansoprazole + Levofloxacin-Based Triple Therapy

Arm 3: Vonoprazan + Levofloxacin-Based Triple Therapy

EXPERIMENTAL

Vonoprazan 20mg BD + Levofloxacin 500mg OD + Amoxicillin 1g BD (for 14 days)

Drug: Arm 3: Vonoprazan + Levofloxacin-Based Triple Therapy

Interventions

Arm 1: Dexlansoprazole + Levofloxacin-Based Triple Therapy DRUG

A combination of Dexlansoprazole (60mg twice daily) with Levofloxacin (500mg once daily) and Amoxicillin (1g twice daily) for the eradication of Helicobacter pylori infection.

Arm 1: Dexlansoprazole + Levofloxacin-Based Triple Therapy

Arm 2: Lansoprazole + Levofloxacin-Based Triple Therapy DRUG

A combination of Lansoprazole (30mg twice daily) with Levofloxacin (500mg once daily) and Amoxicillin (1g twice daily) for the eradication of Helicobacter pylori infection.

Arm 2: Lansoprazole + Levofloxacin-Based Triple Therapy

Arm 3: Vonoprazan + Levofloxacin-Based Triple Therapy DRUG

A combination of Vonoprazan (20mg twice daily) with Levofloxacin (500mg once daily) and Amoxicillin (1g twice daily) for the eradication of Helicobacter pylori infection.

Arm 3: Vonoprazan + Levofloxacin-Based Triple Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Sindh Institute of Advanced Endoscopy and Gastroenterology (SIAG), DUHS

Karachi, 75600, Pakistan

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

PA (1)