Helicobacter Pylori InfectionNCT04621487
Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection
A study testing Amoxicillin, Metronidazole and Clarithromycin in people with Helicobacter Pylori Infection, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Amoxicillin, Metronidazole and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Jan 2019to 15 Feb 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- helicobacter pylori infection
Who cannot join
- previous unsuccessful eradication treatment, stomach or other malignancy, taking of proton pump inhibitors, H2-antagonists, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in the previous month, significant comorbidities (renal insufficiency, psychiatric disease), denial to participate in the study, history of allergy to proton pump inhibitors or antibiotics, pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial: Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection
Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. As a result of concurrent administration this therapy has given better results according to some studies in comparison to sequential variants. However, this therapy, as well suffers from the aforementioned increase in antibiotic resistance. Therefore, the aim of this study was to compare concomitant non-bismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing.
Read the detailed description
More than half of world population are H.pylori carriers. The infection is mostly acquired in childhood and persists lifelong. A notable risk factor is a lower social and economic status during childhood reflecting mostly poor hygienic standard or small and dense living area. Newly acquired infections in adulthood are a rarity. The reservoir of H. Pylori is the human stomach. H. pylori is considered to be the main pathogen involved in causing benign peptic ulcer and functional dyspepsia as well as gastric cancer. The treatment of H. Pylori infection is currently complicated by an increase in antimicrobial resistance in different parts of the world. Corresponding increase in clarithromycin as well as quinolone and metronidazole resistance poses a major clinical problem and calls for a new approach to treatment. Under such circumstances there is an emerging trend towards personalized eradication therapy. Since H. Pylori infection is an infectious disease its optimal treatment should both theoretically and practically be based on the specific characteristics of the strain and if possible the host of the infection. The aim of such an approach should be a better eradication efficacy.
Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. As a result of concurrent administration this therapy has given better results according to some studies in comparison to sequential variants. However, this therapy, as well suffers from the aforementioned increase in antibiotic resistance. Therefore, the aim of this study was to compare concomitant non-bismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing assuming that eradication rate with tailored therapy will be above 90%.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Amoxicillin, Metronidazole, Clarithromycin, Pantoprazole 40mg, according to antibiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
14 days 1 gr bid
MetronidazoleDrug
14 days 500 mg bid
ClarithromycinDrug
14 days 500 mg bid
Pantoprazole 40mgDrug
Also called Pantoprazole
40 mg bid 14 days
according to antibiogramDrug
according to antibiogram
| Study group | Role | What they receive |
|---|---|---|
| concomitant | Active comparator | Concomitant therapy consists of 14 days pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, metronidazole 500 mg all twice daily. Receives: Drug: Amoxicillin; Drug: Metronidazole; Drug: Clarithromycin; Drug: Pantoprazole 40mg |
| tailored | Active comparator | Tailored therapy consists of 14 days antibiotic therapy according to H. Pylori strains antibiotic sensitivity test together with pantoprazole 40 mg twice daily. Receives: Drug: according to antibiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication
H.pylori status will be tested 1 month after therapy with a stool antigen test: positive or negative
Measured: 1 month after finishing therapy
Secondary outcomes (2)
compliance
compliance will be measured by counting pills that were taken during therapy, more than or equal to 80% will be considered as good compliance
Measured: 1 month after finishing therapy
adverse event
patients will be asked to report any adverse events that occurred during treatment, they will be divided in groups, according to the degree of limitation of daily activities: no adverse events, mild (no limitations of activities), moderate (partially limited activities), severe (completely limited)
Measured: 1 month after finishing therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start15 Jan 2019
- Primary completion15 Jan 2020
- Study completion15 Feb 2020
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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikola Perkovic, MD, Principal investigator, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621487
- Sponsor's protocol ID
- 004/08-19-03
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 9 Nov 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 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial: Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT04621487
- Acronym / sponsor ID
- 004/08-19-03
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 9 Nov 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.
Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. As a result of concurrent administration this therapy has given better results according to some studies in comparison to sequential variants. However, this therapy, as well suffers from the aforementioned increase in antibiotic resistance. Therefore, the aim of this study was to compare concomitant non-bismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing.
Detailed description
More than half of world population are H.pylori carriers. The infection is mostly acquired in childhood and persists lifelong. A notable risk factor is a lower social and economic status during childhood reflecting mostly poor hygienic standard or small and dense living area. Newly acquired infections in adulthood are a rarity. The reservoir of H. Pylori is the human stomach. H. pylori is considered to be the main pathogen involved in causing benign peptic ulcer and functional dyspepsia as well as gastric cancer. The treatment of H. Pylori infection is currently complicated by an increase in antimicrobial resistance in different parts of the world. Corresponding increase in clarithromycin as well as quinolone and metronidazole resistance poses a major clinical problem and calls for a new approach to treatment. Under such circumstances there is an emerging trend towards personalized eradication therapy. Since H. Pylori infection is an infectious disease its optimal treatment should both theoretically and practically be based on the specific characteristics of the strain and if possible the host of the infection. The aim of such an approach should be a better eradication efficacy.
Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. As a result of concurrent administration this therapy has given better results according to some studies in comparison to sequential variants. However, this therapy, as well suffers from the aforementioned increase in antibiotic resistance. Therefore, the aim of this study was to compare concomitant non-bismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing assuming that eradication rate with tailored therapy will be above 90%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concomitant | Active comparator | Drug: Amoxicillin, Drug: Metronidazole, Drug: Clarithromycin, Drug: Pantoprazole 40mgConcomitant therapy consists of 14 days pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, metronidazole 500 mg all twice daily. |
| tailored | Active comparator | Drug: according to antibiogramTailored therapy consists of 14 days antibiotic therapy according to H. Pylori strains antibiotic sensitivity test together with pantoprazole 40 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- helicobacter pylori infection
Key exclusion criteria (1 listed)
- previous unsuccessful eradication treatment, stomach or other malignancy, taking of proton pump inhibitors, H2-antagonists, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in the previous month, significant comorbidities (renal insufficiency, psychiatric disease), denial to participate in the study, history of allergy to proton pump inhibitors or antibiotics, pregnancy and lactation.
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 |
|---|---|---|
| Amoxicillin14 days 1 gr bid | Drug | concomitant |
| Metronidazole14 days 500 mg bid | Drug | concomitant |
| Clarithromycin14 days 500 mg bid | Drug | concomitant |
| Pantoprazole 40mgAlso: Pantoprazole40 mg bid 14 days | Drug | concomitant |
| according to antibiogramaccording to antibiogram | Drug | tailored |
Primary outcome
eradication
Time frame: 1 month after finishing therapy
H.pylori status will be tested 1 month after therapy with a stool antigen test: positive or negative
2 secondary outcomes
compliance
Time frame: 1 month after finishing therapy
adverse event
Time frame: 1 month after finishing therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: No
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HELICOBACTER PYLORI INFECTIONS
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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.
Nikola Perkovic, MD principal investigator
University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin, Metronidazole and Clarithromycin in people with Helicobacter Pylori Infection, run by University of Split, School of Medicine at 1 site in Croatia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eradication (time frame: 1 month after finishing therapy). 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 9 Nov 2020.