Helicobacter Pylori InfectionPhase 4NCT04090021
Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.
A Phase 4 study testing Esomeprazole 40mg, Clarithromycin 500mg and Metronidazole 500 mg in people with Helicobacter Pylori Infection, run by Konstantopoulio-Patission General Hospital of Nea Ionia at 1 site in Greece.
Trial summary
This study aims to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole 40mg, Clarithromycin 500mg and Metronidazole 500 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2019to 28 Feb 2020
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive outpatients aged ≥18 years with documented H. pylori infection. Mental and legal ability to provide written informed consent.
Who cannot join
- previous history of H. pylori eradication therapy
- history of allergies to the medications used
- previous esophageal or gastric surgery
- serious systemic disease
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Konstantopoulio-Patision General Hospital
Athens, Nea Ionia, 14233
Vasilios Papastergiou, MD, +302132057018, gastrenterologiki@konstantopouleio.gr
About this study
Official title: Genotypic Resistance-guided Triple Therapy Versus Empirical Concomitant Therapy for First-line H. Pylori Eradication.
This study aims to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.
Read the detailed description
Empiric eradication of H. pylori becomes steadily more challenging because of increasing antibiotic resistance. In high-resistance countries where bismuth and/or tetracycline are unavailable (eg; Greece), non-bismuth quadruple therapies are currently recommended as first-line therapeutic options; however, eradication rates >95% are infrequently achieved and even >90% are disputed. Antimicrobial susceptibility-guided therapy is a promising alternative in order to maintain high therapeutic efficacy. However, traditional culture-based susceptibility testing methods have several shortcomings, including they are time-consuming and they do not 100% reflect in vivo eradication. Recent guidelines also recommend the use of molecular testing for evaluation of H. pylori antibiotic susceptibility. Nevertheless, the efficacy of genotypic resistance-guided treatment of H. pylori has been seldom appraised. Therefore, the investigators conducted this prospective randomized controlled trial aiming to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole 40mg, Clarithromycin 500mg, Metronidazole 500 mg, Amoxicillin 1000 MG, Levofloxacin 500mg
- Keywords
- H. pylori, genotypic resistance, tailored therapy, concomitant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40mgDrug
Use in a drug combination for H. pylori eradication
Clarithromycin 500mgDrug
Use in a drug combination for H. pylori eradication
Metronidazole 500 mgDrug
Use in a drug combination for H. pylori eradication
Amoxicillin 1000 MGDrug
Use in a drug combination for H. pylori eradication
Levofloxacin 500mgDrug
Use in a drug combination for H. pylori eradication
Rifabutin 150 MGDrug
Use in a drug combination for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Genotypic resistance-guided triple therapy | Experimental | In the group of genotypic resistance-guided triple therapy, a molecular assay based on DNA-strip technology was used to determine the genotypic resistance of H. Pylori to clarithromycin (23SrRNA mutations) and fluoroquinolones (gyrA mutations) from gastric biopsy specimens. According to 23SrRNA and gyrA mutational analyses, a 7-day tailored triple therapy therapy was given as follows:
Wild-type 23SrRNA: Clarithromycin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d.
23SrRNA mutated/wild-type gyrA: Levofloxacin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g b.i.d. and levofloxacin 500 mg b.i.d.
23SrRNA mutated/gyrA mutated: Rifabutin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g t.i.d. and rifabutin 150 mg b.i.d. Receives: Drug: Esomeprazole 40mg; Drug: Clarithromycin 500mg; Drug: Amoxicillin 1000 MG; Drug: Levofloxacin 500mg; Drug: Rifabutin 150 MG |
| Empirical concomitant therapy | Active comparator | In the empirical concomitant group, patients received esomeprazole 40mg, amoxicillin 1gr, clarithromycin 500mg and metronidazole 500mg, all b.i.d., for 10-14 days. Receives: Drug: Esomeprazole 40mg; Drug: Clarithromycin 500mg; Drug: Metronidazole 500 mg; Drug: Amoxicillin 1000 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of H. pylori eradication
Rate of H. pylori eradication by intention to treat/per protocol in each group at least 6 weeks after treatment completion using the urea breath test.
Measured: At least 6 weeks after treatment completion
Secondary outcomes (2)
Rate of adverse effects
Adverse events were investigated by means of a structured clinical interview immediately after the completion of therapy. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).
Measured: At least 6 weeks after treatment completion
Compliance rates
Drug compliance was determined by counting unused medication. For this purpose, any tablet that was not consumed was brought back to the clinic for pill count. Poor compliance was defined as taking less than 80% of the total medication prescribed.
Measured: At least 6 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Sep 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konstantopoulio-Patission General Hospital of Nea Ionia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasilios Papastergiou, Konstantopoulio-Patission General Hospital of Nea Ionia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090021
- Sponsor's protocol ID
- 10548
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotypic Resistance-guided Triple Therapy Versus Empirical Concomitant Therapy for First-line H. Pylori Eradication.
- ClinicalTrials.gov ID
- NCT04090021
- Acronym / sponsor ID
- 10548
- Conditions
- Helicobacter Pylori Infection
- Keywords
- H. pylori, genotypic resistance, tailored therapy, concomitant therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Konstantopoulio-Patission General Hospital of Nea IoniaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 16 Sep 2019 (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.
This study aims to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.
Detailed description
Empiric eradication of H. pylori becomes steadily more challenging because of increasing antibiotic resistance. In high-resistance countries where bismuth and/or tetracycline are unavailable (eg; Greece), non-bismuth quadruple therapies are currently recommended as first-line therapeutic options; however, eradication rates >95% are infrequently achieved and even >90% are disputed. Antimicrobial susceptibility-guided therapy is a promising alternative in order to maintain high therapeutic efficacy. However, traditional culture-based susceptibility testing methods have several shortcomings, including they are time-consuming and they do not 100% reflect in vivo eradication. Recent guidelines also recommend the use of molecular testing for evaluation of H. pylori antibiotic susceptibility. Nevertheless, the efficacy of genotypic resistance-guided treatment of H. pylori has been seldom appraised. Therefore, the investigators conducted this prospective randomized controlled trial aiming to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotypic resistance-guided triple therapy | Experimental | Drug: Esomeprazole 40mg, Drug: Clarithromycin 500mg, Drug: Amoxicillin 1000 MG, Drug: Levofloxacin 500mg, Drug: Rifabutin 150 MGIn the group of genotypic resistance-guided triple therapy, a molecular assay based on DNA-strip technology was used to determine the genotypic resistance of H. Pylori to clarithromycin (23SrRNA mutations) and fluoroquinolones (gyrA mutations) from gastric biopsy specimens. According to 23SrRNA and gyrA mutational analyses, a 7-day tailored triple therapy therapy was given as follows: Wild-type 23SrRNA: Clarithromycin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. 23SrRNA mutated/wild-type gyrA: Levofloxacin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g b.i.d. and levofloxacin 500 mg b.i.d. 23SrRNA mutated/gyrA mutated: Rifabutin-based triple therapy comprising esomeprazole 40 mg b.i.d., amoxicillin 1 g t.i.d. and rifabutin 150 mg b.i.d. |
| Empirical concomitant therapy | Active comparator | Drug: Esomeprazole 40mg, Drug: Clarithromycin 500mg, Drug: Metronidazole 500 mg, Drug: Amoxicillin 1000 MGIn the empirical concomitant group, patients received esomeprazole 40mg, amoxicillin 1gr, clarithromycin 500mg and metronidazole 500mg, all b.i.d., for 10-14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive outpatients aged ≥18 years with documented H. pylori infection. Mental and legal ability to provide written informed consent.
Key exclusion criteria (5 listed)
- previous history of H. pylori eradication therapy
- history of allergies to the medications used
- previous esophageal or gastric surgery
- serious systemic disease
- pregnancy or 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 |
|---|---|---|
| Esomeprazole 40mgUse in a drug combination for H. pylori eradication | Drug | Empirical concomitant therapy, Genotypic resistance-guided triple therapy |
| Clarithromycin 500mgUse in a drug combination for H. pylori eradication | Drug | Empirical concomitant therapy, Genotypic resistance-guided triple therapy |
| Metronidazole 500 mgUse in a drug combination for H. pylori eradication | Drug | Empirical concomitant therapy |
| Amoxicillin 1000 MGUse in a drug combination for H. pylori eradication | Drug | Empirical concomitant therapy, Genotypic resistance-guided triple therapy |
| Levofloxacin 500mgUse in a drug combination for H. pylori eradication | Drug | Genotypic resistance-guided triple therapy |
| Rifabutin 150 MGUse in a drug combination for H. pylori eradication | Drug | Genotypic resistance-guided triple therapy |
Primary outcome
Rate of H. pylori eradication
Time frame: At least 6 weeks after treatment completion
Rate of H. pylori eradication by intention to treat/per protocol in each group at least 6 weeks after treatment completion using the urea breath test.
2 secondary outcomes
Rate of adverse effects
Time frame: At least 6 weeks after treatment completion
Compliance rates
Time frame: At least 6 weeks after treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- 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.
Konstantopoulio-Patision General Hospital
Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole 40mg, Clarithromycin 500mg and Metronidazole 500 mg in people with Helicobacter Pylori Infection, run by Konstantopoulio-Patission General Hospital of Nea Ionia at 1 site in Greece.
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 5 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 19 Sep 2019. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of H. pylori eradication (time frame: At least 6 weeks after treatment completion). 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 19 Sep 2019.