Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Vonoprazan, Amoxicillin and Levofloxacin; Drug: Pantoprazole 40mg, Amoxicillin and Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT06414707

FMASU R288/2023

Details and patient eligibility

About

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).

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Vonoprazan Group

Active Comparator group

Description:

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.

Treatment:

Drug: Vonoprazan, Amoxicillin and Levofloxacin

Pantoprazole Group

Active Comparator group

Description:

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

Treatment:

Drug: Pantoprazole 40mg, Amoxicillin and Levofloxacin