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Completed

NCT Number: NCT04769583

14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fattouma Bourguiba Hospital

Monastir, Tunisia

About this study

This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist.

The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.

H. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged between 18 and 65, with documented Hp infection.

Exclusion criteria

are excluded patients:

  • With Cirrhosis.
  • With Renal failure (serum creatinine> 120 µmol / L).
  • Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.
  • Having severe psychiatric disorders.
  • Having had gastric surgery in their history.
  • Having already received an HP eradication treatment.
  • Having received an antibiotic within the last two weeks.
  • Who are allergic to one of the antibiotics used in the anti-Hp cure.
  • Who are drug addicted.

Treatment and study plan

metronidazole based quadriple therapy

Drug

patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)

Other names: concomitant quadruple therapy (QC)

placebo based quadriple therapy

Drug

patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.

Other names: Triple therapy (TT)

Primary outcomes

  1. HP eradiction rate

    Time frame: 6 weeks after completion of study treatment

    assessment by breath test

Secondary outcomes

  1. percentage of adverse reactions

    Time frame: 3 months

    we will determinate the percentage of adverse reactions in each group of treatment.

Sponsors and collaborators

Lead sponsor

mohamed bouchoucha

Industry

Registry information

Official study title

A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.

Acronym: HEPRA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2021
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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