Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori

May 13, 2024 updated by: Ain Shams University

Efficacy of Vonoprazan Versus Proton Pump Inhibitors in Combination With Antibiotics as a Triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori

The goal of this Randomized controlled trial is to assessment Efficacy of Vonoprazan versus Proton Pump Inhibitors in Combination with Antibiotics as a triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori (H. pylori).

This randomized controlled study was performed on 2 groups of Egyptian patients diagnosed with dyspepsia; group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days and group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days. All patients of the two groups were followed up for persistence of infection 8 weeks after the end of treatment by testing fecal H. pylori antigen (Ag).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial included two groups of Egyptian patients diagnosed with dyspepsia related to Clarithromycin-resistant strains of H.pylori.

  • Group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for two weeks.
  • Group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days.

The included cases were collected from gastroenterology outpatient clinic and inpatient department at Ain shams University hospital between October 2023 and April 2024.

The work had been conducted after the scientific ethics committee approval and after obtaining an informed consent from all the included cases.

All cases were diagnosed with H. Pylori resistant infection after clarithromycin based treatment regimen for H. pylori confirmed with persistent positive test of fecal H. pylori Ag before the starting of the study.

All patients of the two groups were followed up for persistence of infection 8-weeks following the end of therapy by testing fecal H. pylori Ag. And the study end-points were compliance failure or gastrointestinal bleeding.

Each participant had been exposed to comprehensive taking of history, full physical assessment, full laboratory examination including (CBC, liver profile (ALT, AST), kidney functions test (S. creat), fecal H. pylori Ag testing before the starting of the trial and another stool sample were taken after termination of treatment by 8 weeks for evaluating of the eradication of H. pylori infection and pelvi-abdominal U/S was done for all patients.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 3

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

  • Egypt
      • Cairo, Egypt, 3753450
        • Mostafa Elfors

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:

  • patients with dyspepsia related to Clarithromycin-resistant strains of H.pylori. All cases were diagnosed with H. Pylori resistant infection after clarithromycin based treatment regimen for H. pylori confirmed with persistent positive test of fecal H. pylori Ag before the starting of the study.
  • Must be able to swallow tablets.

Exclusion Criteria:

  • Cases with drug allergy from drugs included in the study.
  • those having inflammatory-bowel diseases.
  • those with malabsorption syndrome.
  • those having gastroenterology malignancy.
  • patients on immunotherapy.
  • HIV patients.

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: Vonoprazan Group
included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for two weeks.
Drug: Vonoprazan, Amoxicillin and Levofloxacin
Group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days.
Other Names:
  • Vonaspire 20 mg
  • Amoxil 1 gm
  • Tavanic 500 mg
Active Comparator: Pantoprazole Group
included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days
Drug: Pantoprazole 40mg, Amoxicillin and Levofloxacin
Group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days.
Other Names:
  • Amoxil 1 gm
  • Tavanic 500 mg
  • controloc 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment the fecal H.Pylori Ag after receiving Vonoprazan in combination with antibiotics as a triple therapy in patients with Clarithromycin-resistant strain of H.Pylori infection.
Time Frame: All patients of the two groups were followed up for 2 months.
comparison between the efficiency of Vonoprazan and Pantoprazole in eradication of Clarithromycin-resistant strain of H.Pylori.
All patients of the two groups were followed up for 2 months.

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

October 12, 2023

Primary Completion (Actual)

April 4, 2024

Study Completion (Actual)

April 4, 2024

Study Registration Dates

First Submitted

April 6, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R288/2023

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

Yes

Studies a U.S. FDA-regulated device product

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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