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

NCT05635942 | Completed Phase 4

• 1 other identifier: HELICO_TEST_2019
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori

Keywords

Disease Eradication

Outcome Measures

Primary Outcomes (1)

• HP eeradication rate

  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.

  6 weeks after treatment completion

Secondary Outcomes (1)

• prevalence of adverse reactions

  6 weeks after treatment completion

Study Arms (2)

optimized quadruple therapy (Qo-14)

EXPERIMENTAL

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

standard quadruple therapy (Qs-14)

ACTIVE COMPARATOR

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

Interventions

optimized quadruple therapy DRUG

Association of amoxicillin 3 g/day + Esomeprazole, nitroimidazole and clarithromycin for 14 days

Also known as: Qo-14

optimized quadruple therapy (Qo-14)

standard quadruple therapy DRUG

Association of amoxicillin 2 g/day + Esomeprazole, nitroimidazole and clarithromycin for 14 days

Also known as: Qs-14

standard quadruple therapy (Qs-14)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• H. pylori infection documented by pathological examination of per endoscopic gastric biopsies.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead

Study Sites (1)

Hepatogastroenterology department of Mahmoud Matri Hospital

Aryanah, 2080, Tunisia

Location

Study Officials

• Lamia Kallel, PhD

  Hospital Mahmoud El Matri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Technicians, who performed culture, antimicrobial susceptibility testing or urea breath test were blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 2, 2022
• Study Start: January 29, 2019
• Primary Completion: August 30, 2022
• Study Completion: November 1, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

TU (1)