14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

NCT ID: NCT04769583

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-10
• Study Completion Date: 2020-03-05

Brief 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.

Detailed 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.

Conditions

Gastritis H Pylori

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

concomitant quadruple therapy (QC)

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

Group Type: ACTIVE_COMPARATOR

metronidazole based quadriple therapy

Intervention Type: 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)

triple therapy (TT)

PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) AND PLACEBO for 14 days.

Group Type: PLACEBO_COMPARATOR

placebo based quadriple therapy

Intervention Type: 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.

Interventions

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)

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

concomitant quadruple therapy (QC); Triple therapy (TT)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

mohamed bouchoucha

INDUSTRY

Sponsor Role: lead

Responsible Party

mohamed bouchoucha

Assistant Clinical Data management

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fattouma Bourguiba Hospital

Monastir, , Tunisia

Countries

Tunisia

Other Identifiers

TN2018-INT-INS-14

Identifier Type: -

Identifier Source: org_study_id