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

NCT04359966 | Unknown DMC

• 1 other identifier: SZGH Krka
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 3

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.

Conditions

Helicobacter Pylori Infection; Eradication Treatments

Keywords

Helicobacter pylori; First line treatment; Second line treatment; susceptibility to antibiotics

Outcome Measures

Primary Outcomes (2)

• Success rate of first line therapy for Helicobacter pylori infection

  Eradication rate

  2 years

• Success rate of second line therapy for Helicobacter pylori infection

  Eradication rate

  3 years

Secondary Outcomes (1)

• Helicobacter pylori resistance rate to antibiotics

  3 years

Study Arms (4)

First line therapy for H pylori infection

ACTIVE COMPARATOR

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

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

First line therapy for H pylori infection second arm

EXPERIMENTAL

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

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

Second line therapy for H pylori infection

ACTIVE COMPARATOR

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.

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

Second line therapy for H pylori infection second arm

EXPERIMENTAL

Tripple second line therapy Esomeprazol 40 mg BID Amoxicillin 1000 mg BID, Levofloxacin 500 mg OID, 14 days or

Drug: Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg

Interventions

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

First line therapy

Also known as: Emozul, Fromilid,Efloran

First line therapy for H pylori infection

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

First line therapy second arm

Also known as: Emozul, Bismut oksid Krka, Hiconcil, Efloran

First line therapy for H pylori infection second arm

Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg DRUG

Second line therapy for Helicobacter pylori infection second arm

Also known as: Emozul, Hiconcil,Tavanic

Second line therapy for H pylori infection second arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Slovenian Society for Gastroenterology and Hepatology: lead
• KRKA: collaborator

Study Sites (3)

DC BLED

Bled, 4260, Slovenia

Location

UCC

Ljubljana, 1000, Slovenia

Location

Am Dc Rogaska

Rogaška Slatina, 3250, Slovenia

Location

MeSH Terms

Interventions

Esomeprazole; Clarithromycin; Metronidazole; bismuth tripotassium dicitrate; Amoxicillin; Levofloxacin; Ofloxacin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• BOJAN TEPES

  AM DC Rogaška

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BOJAN TEPES

CONTACT

0038641325916; bojan.tepes@siol.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised procpective multicenter trial

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 24, 2020
• Study Start: May 10, 2020
• Primary Completion: May 31, 2023
• Study Completion: September 30, 2023
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (3)