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

• ClinicalTrials.gov Identifier: NCT04769583
• Recruitment Status: Completed
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Sponsor: mohamed bouchoucha
• Information provided by (Responsible Party): mohamed bouchoucha, Les Laboratoires des Médicaments Stériles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastritis H Pylori	Drug: metronidazole based quadriple therapy; Drug: placebo based quadriple therapy	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: a placebo which has the same visual characteristics as metronidazole in the boxes of the triple therapy
• Primary Purpose: Treatment
• Official Title: A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.
• Actual Study Start Date: February 10, 2019
• Actual Primary Completion Date: February 17, 2020
• Actual Study Completion Date: March 5, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	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); Other Name: concomitant quadruple therapy (QC)
Placebo Comparator: 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.	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.; Other Name: Triple therapy (TT)

Outcome Measures

Primary Outcome Measures :

1. HP eradiction rate [ Time Frame: 6 weeks after completion of study treatment ]
   assessment by breath test

Secondary Outcome Measures :

1. percentage of adverse reactions [ Time Frame: 3 months ]
   we will determinate the percentage of adverse reactions in each group of treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Tunisia

Fattouma Bourguiba Hospital

Monastir, Tunisia

Sponsors and Collaborators

mohamed bouchoucha

More Information

• Responsible Party: mohamed bouchoucha, Assistant Clinical Data management, Les Laboratoires des Médicaments Stériles
• ClinicalTrials.gov Identifier: NCT04769583
• Other Study ID Numbers: TN2018-INT-INS-14
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by mohamed bouchoucha, Les Laboratoires des Médicaments Stériles:

Breath Tests; Helicobacter pylori

Additional relevant MeSH terms:

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Metronidazole; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents