14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

Gastritis H Pylori Clinical Trial

— HEPRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769583
• Other study ID #: TN2018-INT-INS-14
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: February 2021
• Source: Les Laboratoires des Médicaments Stériles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 5, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastritis
• Gastritis H Pylori

Intervention

Drug:
• metronidazole based quadriple therapy
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)
• placebo based quadriple therapy
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.

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba Hospital	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
mohamed bouchoucha

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HP eradiction rate	assessment by breath test	6 weeks after completion of study treatment
Secondary	percentage of adverse reactions	we will determinate the percentage of adverse reactions in each group of treatment.	3 months