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Helicomatri: Optimized-dose Amoxicillin Versus Standard-dose Amoxicillin for Quadruple Therapy in Helicobacter Pylori Eradication

Sponsor
Les Laboratoires des Médicaments Stériles (Industry)
Overall Status
Completed
CT.gov ID
NCT05635942
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
45.1
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this prospective randomized clinical trial is to compare the rate of Helicobacter Pylori (HP) eradication after standard or dose-optimized amoxicillin quadritherapy in patients naïve to any anti-HP treatment and with chronic HP infection documented by histological examination. The main questions it aims to answer are:

  • compare the eradication rate of H.Pylori after a standard concomitant quadritherapy with 2g of amoxicillin versus an optimized quadritherapy with 3g of amoxicillin, in Tunisian population

  • Identify different factors associated with poor therapeutic response Patients were randomly assigned to either standard quadruple therapy (Qs-14: amoxicillin 1g twice daily, clarithromycin 500mg twice daily, metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days), or optimized quadruple therapy (Qo-14: amoxicillin 1g three times a day, clarithromycin 500mg twice daily, metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days). Eradication control was performed by urea breath test.

Condition or Disease Intervention/Treatment Phase
  • Drug: optimized quadruple therapy
  • Drug: standard quadruple therapy
 Phase 4

Detailed Description

This study was a prospective, randomized, single-center study conducted in the hepato-gastroenterology department of Mahmoud Matri Hospital in Ariana, in collaboration with the bacteriology and biochemistry laboratory of the same hospital, the anatomopathology department of Abderrahmen Mami Hospital in Ariana, and the private clinical analysis laboratory "Fendri". all patients aged from 18 and 65 years-old with H. pylori infection documented by pathological examination of per endoscopic gastric biopsies were recruited.

This was a population of patients who had undergone upper endoscopy (UE) and in whom the search for H.Pylori was indicated, according to the European Maastrich IV recommendations.

Eligible subjects were randomly assigned in a 1:1 ratio to receive either standard quadruple therapy (Qs-14) including : amoxicillin 1g twice daily ,clarithromycin 500mg twice daily ,metronidazole 500mg twice daily and esomeprazole (Medis Pharmaceutical Company) 40 mg twice daily for 14 days, or optimized quadruple therapy (Qo-14) including : amoxicillin 1g three times daily ,clarithromycin 500mg twice daily, metronidazole 500mg twice daily and esomeprazole 40 mg twice daily (Medis Pharmaceutical Company) for 14 days.

Eradication control was performed by 13C-UBT at least 4 weeks after the end of the treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Technicians, who performed culture, antimicrobial susceptibility testing or urea breath test were blinded to treatment allocation.
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Trial: Comparison Between Optimized-dose Amoxicillin and Standard-dose Amoxicillin for Quadruple Therapy in the Treatment of Helicobacter Pylori Infection in Tunisian Patients
Actual Study Start Date :
Jan 29, 2019
Actual Primary Completion Date :
Aug 30, 2022
Actual Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: optimized quadruple therapy (Qo-14)

patients allocated to experimental group receive an optimized quadruple therapy (Qo-14) including 3 grams of Amoxicillin plus standard dose of clarithromycin, metronidazole and esomeprazole for 14 days.

Drug: optimized quadruple therapy
Association of amoxicillin 3 g/day + Esomeprazole, nitroimidazole and clarithromycin for 14 days
Other Names:
  • Qo-14

    		•
    Active Comparator: standard quadruple therapy (Qs-14)

    patients allocated to this group receive standard quadruple therapy (Qs-14) including : amoxicillin 1g twice daily ,clarithromycin 500mg twice daily ,metronidazole 500mg twice daily and esomeprazole 40 mg twice daily for 14 days

    Drug: standard quadruple therapy
    Association of amoxicillin 2 g/day + Esomeprazole, nitroimidazole and clarithromycin for 14 days
    Other Names:
  • Qs-14

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HP eeradication rate [6 weeks after treatment completion]

      Urea Breath test (UBT) is performed no sooner than 6 weeks after completion of H pylori therapy. Use of PPIs should be discontinued for at least 2 weeks before administration of the UBT.

    Secondary Outcome Measures

    1. prevalence of adverse reactions [6 weeks after treatment completion]

      The percentage of patients reporting side effects during treatment and the following days until the evaluation of Hp eradication

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. pylori infection documented by pathological examination of per endoscopic gastric biopsies.
    Exclusion Criteria:

    • Previously received H.Pylori eradication therapy. Known allergy to one of the components of the kit used (Helikit) for 13C-urea breath test (UBT).

    • A contraindication to 13C-UBT. Allergy or contraindication to the following antibiotics: Amoxicillin, Clarithromycin, Metronidazole and quinolones.

    • Received antibiotics during the four weeks, or proton pump inhibitors (PPIs) during the two weeks prior to inclusion in the study.

    • A history of bariatric surgery. Active gastro intestinal bleeding.

    • Severe comorbidity such as decompensated cirrhosis, end-stage renal disease, decompensated cardiac disease and neoplastic disease.

    • Patients on long-term immunosuppressive or corticosteroid therapy at a dose greater than 20mg/day.

    • Pregnant or lactating women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hepatogastroenterology department of Mahmoud Matri Hospital Ariana Tunisia 2080

    Sponsors and Collaborators

    • Les Laboratoires des Médicaments Stériles

    Investigators

    • Principal Investigator: Lamia Kallel, PhD, Hospital Mahmoud El Matri

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Les Laboratoires des Médicaments Stériles
    ClinicalTrials.gov Identifier:
    NCT05635942
    Other Study ID Numbers:
    • HELICO_TEST_2019
    First Posted:
    Dec 2, 2022
    Last Update Posted:
    Dec 2, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Les Laboratoires des Médicaments Stériles
    Disease Eradication

    Study Results

    No Results Posted as of Dec 2, 2022