Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia

NCT ID: NCT04359966

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-10
• Study Completion Date: 2023-09-30

Brief Summary

Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure of first-line treatment) in patients with H. pylori infection. The secondary objective of the study is to determine the primary resistance of H. pylori to antibiotics in Slovenia.

Detailed Description

The infection with Helicobacter pylori is extremely widespread, as 60% of the world's population is infected. In Slovenia, the average prevalence is 25.1 %, the prevalence in the 20-year age group is 20 % and 76 % in patients in age group 50 - 75 years. All infected patients have active chronic gastritis, which is asymptomatic in most cases. Ulcers in the stomach or duodenum occurs in 15 % of patients. Due to chronic infection, MALT lymphoma or gastric cancer develop in 1 - 3 % of patients. According to the recommendations of the Slovenian Association for Gastroenterology and Hepatology, as well as European and other recommendations, everyone who is infected with Helicobacter pylori should be treated. H. pylori is a first-class carcinogen and is responsible for 50 % of all chronic cancer-causing infections in the developed world. Therefore, it is necessary to start programs of primary and secondary prevention of gastric cancer by searching and treating infected patients.

Patients infected with H. pylori who have not yet been treated will be randomly assigned to two first-line treatment groups:

Group 1: Esomeprazole 40 mg, Clarithromycin 500 mg, Amoxicillin 1000 mg, all BID,14 days Group 2: Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg, all QID Esomeprazole 40 mg BID, 14 days

Patients unsuccessfully treated with first-line therapy will be randomly assigned to two second-line treatment groups:

Group 1: Esomeprazole 40 mg BID, Levofloxacin 500 mg OID, Amoxicillin 1000 mg BID, 14 days Group 2: Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days

Inclusion criteria :

Patients 18 to 80 years of age. Patients have not received proton pump inhibitors for the past 14 days. Patients did not receive antibiotics last month. Helicobacter pylori infection has been demonstrated by rapid urease test

Exclusion criteria :

Prior treatment for Helicobacter pylori infection (in patients who will receive Schedule 1 eradication therapy).

Defects in blood clotting. taking anticoagulant medicines that make it impossible to take biopsies.

Drug allergy used in the study. Pregnancy, breastfeeding. Psychiatric illness that would prevent research participation. Active treatment for malignancy.

Statistical analysis:

To describe the variables, we will use the average value and standard deviation for the symmetrically distributed variables or median and 25th and 75th percentiles for asymmetrically distributed variables. Investigators will use the t-test for dependent variables or, in the case of asymmetrically distributed variables, the Wilcoxon test. To determine the differences between the two groups (Group 1 and Group 2) of the subjects, t-test for independent samples Will be used, or in the case of an asymmetrically distributed variables Mann-Whitney test.

Conditions

Helicobacter Pylori Infection; Eradication Treatments

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First line therapy for H pylori infection

Tripple 14 day first line therapy Esomeprazole 40 mg, Clarithromycin 500 mg, Amoxicillin 1000 mg, all BID 14 days

Group Type: ACTIVE_COMPARATOR

Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,

Intervention Type: DRUG

First line therapy

First line therapy for H pylori infection second arm

Bismuth quadruple first line therapy

Bismuth subcitrat 120 mg , Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days.

Group Type: EXPERIMENTAL

Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg

Intervention Type: DRUG

First line therapy second arm

Second line therapy for H pylori infection

Bismuth quadruple second line therapy for those treated with Tripple first line therapy

Bismuth subcitrat 120 mg , Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days.

Group Type: ACTIVE_COMPARATOR

Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg

Intervention Type: DRUG

Second line therapy for Helicobacter pylori infection

Second line therapy for H pylori infection second arm

Tripple second line therapy

Esomeprazol 40 mg BID Amoxicillin 1000 mg BID, Levofloxacin 500 mg OID, 14 days or

Group Type: EXPERIMENTAL

Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg

Intervention Type: DRUG

Second line therapy for Helicobacter pylori infection second arm

Interventions

Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,

First line therapy

Intervention Type: DRUG

Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg

First line therapy second arm

Intervention Type: DRUG

Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg

Second line therapy for Helicobacter pylori infection

Intervention Type: DRUG

Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg

Second line therapy for Helicobacter pylori infection second arm

Intervention Type: DRUG

Other Intervention Names

Emozul, Fromilid,Efloran; Emozul, Bismut oksid Krka, Hiconcil, Efloran; Emozul, Bismut oksid Krka, Hiconcil, Efloran; Emozul, Hiconcil,Tavanic

Eligibility Criteria

Inclusion Criteria

• Patients 18 to 80 years of age.
• Patients have not received proton pump inhibitors for the past 14 days.
• Patients did not receive antibiotics in the last month.
• Helicobacter pylori infection has been demonstrated by rapid urease test.

Exclusion Criteria

• Prior treatment for Helicobacter pylori infection (in patients who will receive Schedule 1 eradication therapy).•
• Defects in blood clotting. taking anticoagulant medicines that make it impossible to take biopsies.
• Allergy to drugs used in the study.
• Pregnancy, breastfeeding shold be excluded.
• Psychiatric illness that would prevent research participation.
• Active treatment for malignancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KRKA

INDUSTRY

Sponsor Role: collaborator

Slovenian Society for Gastroenterology and Hepatology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BOJAN TEPES

Role: PRINCIPAL_INVESTIGATOR

AM DC Rogaška

Locations

DC BLED

Bled, , Slovenia

UCC

Ljubljana, , Slovenia

Am Dc Rogaska

Rogaška Slatina, , Slovenia

Countries

Slovenia

Central Contacts

BOJAN TEPES

Role: CONTACT

bojan.tepes@siol.net

0038641325916 ext. 0038641325916

Facility Contacts

Milan Stefanovič

Role: primary

milan.stefanovic@dc-bled.si

Borut Stabuc, MD PhD

Role: primary

borut.stabuc@kclj.si

Prof B TEPES

Role: primary

bojan.tepes@siol.net

0038641325916 ext. 0038641325916

Other Identifiers

SZGH Krka

Identifier Type: -

Identifier Source: org_study_id