14-day Quadruple Therapy Versus Triple Therapy in HP Eradication (HEPRA)

Sterile Drug Laboratories (MEDIS)

Status and phase: Completed; Phase 4

Conditions: Gastritis H Pylori

Treatments: Drug: metronidazole based quadriple therapy; Drug: placebo based quadriple therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04769583

TN2018-INT-INS-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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121 participants in 2 patient groups, including a placebo group

concomitant quadruple therapy (QC)

Active Comparator group

Description:

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

Treatment:

Drug: metronidazole based quadriple therapy

triple therapy (TT)

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo based quadriple therapy