Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori (SHARE2401)

November 27, 2024 updated by: Yanqing Li, Shandong University

Triple Versus Quadruple Therapy with Amoxicillin and Tetracycline for the Eradication of Helicobacter Pylori: a Multicenter Randomized Controlled Trial

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

H. pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention:

14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 18-70 years old;
  2. Patients with H.pylori infection (positive rapid urease test, 13C/14C-urea breath test);
  3. Patients without previous treatment for H. pylori eradication.

Exclusion Criteria:

  1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%;
  2. Patients with active gastrointestinal bleeding;
  3. Patients with a history of upper gastrointestinal surgery;
  4. Patients allergic to treatment drugs;
  5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks;
  6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial;
  7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse;
  8. Patients who are unwilling or incapable to provide informed consents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 14-day quadruple regimen
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
Drug: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
Other Names:
  • Amoxicillin
  • Bismuth
  • Tetracycline
  • Vonoprazan
  • 14 days
Experimental: 14-day triple regimen
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
Other Names:
  • Amoxicillin
  • Tetracycline
  • Vonoprazan
  • 14 days
Experimental: 7-day triple regimen
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days
Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days
Other Names:
  • Amoxicillin
  • Tetracycline
  • Vonoprazan
  • 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate
Time Frame: Immediately after follow-up check
13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Immediately after follow-up check

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse reactions
Time Frame: Immediately after follow-up check
A questionnaire on drug-related adverse reactions needs to be completed after treatment.
Immediately after follow-up check
Patient compliance
Time Frame: Immediately after follow-up check
A questionnaire on the number of missed and overdosed doses of medication needs to be completed after treatment. Good compliance was defined as taking 80%-120% of the pills.
Immediately after follow-up check

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Zaozhuang Municipal Hospital
Zibo Maternal and Child Health Hospital
Binzhou Maternal and Child Health Hospital
Linyi Yizhou Hospital
Feicheng Municipal People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHARE2401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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