Helicobacter Pylori InfectionNCT04359966
Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia
A study testing Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,, Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg and Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg in people with Helicobacter Pylori Infection and Eradication Treatments, run by Slovenian Society for Gastroenterology and Hepatology at 3 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection, Eradication Treatments
- What is being tested?
- Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,, Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg and Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 3 sitesSlovenia
- Study dates
- 10 May 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites
DC BLED
Bled, 4260
Milan Stefanovič, milan.stefanovic@dc-bled.si
Milan Stefanovič, MD
UCC
Ljubljana, 1000
Borut Stabuc, MD PhD, borut.stabuc@kclj.si
Borut Stabuc, MD PhD
Am Dc Rogaska
Rogaška Slatina, 3250
Prof B TEPES, 0038641325916 ext. 0038641325916, bojan.tepes@siol.net
About this study
Official title: Prospective Randomised Trial of First and Second Line Treatments of Helicobacter Pylori Infection in Slovenia
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.
Read the 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.
- Being tested
- Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,, Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg, Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg
- Keywords
- Helicobacter pylori, First line treatment, Second line treatment, susceptibility to antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,Drug
Also called Emozul, Fromilid,Efloran
First line therapy
Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mgDrug
Also called Emozul, Bismut oksid Krka, Hiconcil, Efloran
First line therapy second arm
Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mgDrug
Also called Emozul, Bismut oksid Krka, Hiconcil, Efloran
Second line therapy for Helicobacter pylori infection
Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mgDrug
Also called Emozul, Hiconcil,Tavanic
Second line therapy for Helicobacter pylori infection second arm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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 Receives: Drug: Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of first line therapy for Helicobacter pylori infection
Eradication rate
Measured: 2 years
Success rate of second line therapy for Helicobacter pylori infection
Eradication rate
Measured: 3 years
Secondary outcomes (1)
Helicobacter pylori resistance rate to antibiotics
Culture and susceptibility testing
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start10 May 2020 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised procpective multicenter trial
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slovenian Society for Gastroenterology and Hepatology
- Sponsor type
- University, hospital or other
- Collaborators
- KRKA
- Responsible party
- Sponsor
- Investigators
- BOJAN TEPES, Principal investigator, AM DC Rogaška
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359966
- Sponsor's protocol ID
- SZGH Krka
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Trial of First and Second Line Treatments of Helicobacter Pylori Infection in Slovenia
- ClinicalTrials.gov ID
- NCT04359966
- Acronym / sponsor ID
- SZGH Krka
- Keywords
- Helicobacter pylori, First line treatment, Second line treatment, susceptibility to antibiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Slovenian Society for Gastroenterology and HepatologyUniversity, hospital or other
- Collaborators
- KRKA
- Study start
- 10 May 2020 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomised procpective multicenter trial
| Arm | Type | Receives |
|---|---|---|
| First line therapy for H pylori infection | Active comparator | Drug: Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,Tripple 14 day first line therapy Esomeprazole 40 mg, Clarithromycin 500 mg, Amoxicillin 1000 mg, all BID 14 days |
| First line therapy for H pylori infection second arm | Experimental | Drug: Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mgBismuth quadruple first line therapy Bismuth subcitrat 120 mg , Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days. |
| Second line therapy for H pylori infection | Active comparator | Drug: Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mgBismuth 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. |
| Second line therapy for H pylori infection second arm | Experimental | Drug: Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mgTripple second line therapy Esomeprazol 40 mg BID Amoxicillin 1000 mg BID, Levofloxacin 500 mg OID, 14 days or |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,Also: Emozul, Fromilid,EfloranFirst line therapy | Drug | First line therapy for H pylori infection |
| Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mgAlso: Emozul, Bismut oksid Krka, Hiconcil, EfloranFirst line therapy second arm | Drug | First line therapy for H pylori infection second arm |
| Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mgAlso: Emozul, Bismut oksid Krka, Hiconcil, EfloranSecond line therapy for Helicobacter pylori infection | Drug | Second line therapy for H pylori infection |
| Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mgAlso: Emozul, Hiconcil,TavanicSecond line therapy for Helicobacter pylori infection second arm | Drug | Second line therapy for H pylori infection second arm |
Primary outcome
Success rate of first line therapy for Helicobacter pylori infection
Time frame: 2 years
Eradication rate
Success rate of second line therapy for Helicobacter pylori infection
Time frame: 3 years
Eradication rate
1 secondary outcome
Helicobacter pylori resistance rate to antibiotics
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BOJAN TEPES principal investigator
AM DC Rogaška
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,, Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg and Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg in people with Helicobacter Pylori Infection and Eradication Treatments, run by Slovenian Society for Gastroenterology and Hepatology at 3 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BOJAN TEPES (0038641325916 ext. 0038641325916, bojan.tepes@siol.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of first line therapy for Helicobacter pylori infection (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.