Helicobacter Pylori InfectionPhase 4NCT03658746
Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection
A Phase 4 study testing two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline), one proton pump inhibitor, colloidal bismuth pectin and two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone) in people with Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline), one proton pump inhibitor, colloidal bismuth pectin and two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 with persistent Helicobacter pylori infection.
- Patients with previous Helicobacter pylori eradication therapy for one or two times.
Who cannot join
- Patients unable or unwilling to receive gastroscopy.
- Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
- Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
- Patients with known or suspected allergy to study medications.
- Currently pregnant or lactating.
- Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection-A Randomized Clinical Trial
The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.
Read the detailed description
Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection.
The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline), one proton pump inhibitor, colloidal bismuth pectin, two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)
- Keywords
- Antimicrobial Susceptibility Testing, Rescue Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)Drug
Patients will receive a 14-day quadruple therapy for the H.pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
one proton pump inhibitor, colloidal bismuth pectinDrug
All patients need these two drugs.
two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)Drug
Patients will receive a 14-day quadruple therapy according to personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient hasn't been treated with levofloxacin previously, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial susceptibility guided therapy | Experimental | Patients in this group will receive a 14-day quadruple therapy for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin, and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d, 2.Colloidal Bismuth Pectin 200mg bid for 14d, 3.two sensitive antibiotics: amoxicillin 1000mg bid for 14d, clarithromycin 500mg bid for 14d, metronidazole 500mg tid for 14d, tinidazole 500mg tid for 14d, levofloxacin 500mg qd for 14d, furazolidone 100mg bid for 14d, tetracycline 500mg qid for 14d. Receives: Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline); Drug: one proton pump inhibitor, colloidal bismuth pectin |
| Empirical therapy according to medication history | Active comparator | Patients in this group will receive a 14-day quadruple therapy based on personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics chosen according to medication history. If the patient hasn't been treated with levofloxacin in the previous eradication regimen, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.
Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and levofloxacin 500mg qd for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d. Receives: Drug: one proton pump inhibitor, colloidal bismuth pectin; Drug: two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rates
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Measured: 6 months
Secondary outcomes (3)
The rates of adverse events happening
Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
Measured: 6 months
The rates of improving dyspepsia symptoms after helicobacter pylori eradication.
Dyspepsia symptoms will also be measured using a 8-point Likert scale.be compared. Common adverse events will be measured using a 8-point Likert scale. Patients rate their symptoms from 0 (none) to 8 (severe) before and after the treatment process.
Measured: 6 months
The rates of good compliance.
Patients taken over 90% of drugs are considered to have a good compliance.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658746
- Sponsor's protocol ID
- 2018SDU-QILU-G003
- Status last verified
- May 2020
- First submitted
- 2 Sep 2018
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection-A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03658746
- Acronym / sponsor ID
- 2018SDU-QILU-G003
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Antimicrobial Susceptibility Testing, Rescue Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Sep 2018 (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.
The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.
Detailed description
Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection.
The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial susceptibility guided therapy | Experimental | Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline), Drug: one proton pump inhibitor, colloidal bismuth pectinPatients in this group will receive a 14-day quadruple therapy for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin, and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d, 2.Colloidal Bismuth Pectin 200mg bid for 14d, 3.two sensitive antibiotics: amoxicillin 1000mg bid for 14d, clarithromycin 500mg bid for 14d, metronidazole 500mg tid for 14d, tinidazole 500mg tid for 14d, levofloxacin 500mg qd for 14d, furazolidone 100mg bid for 14d, tetracycline 500mg qid for 14d. |
| Empirical therapy according to medication history | Active comparator | Drug: one proton pump inhibitor, colloidal bismuth pectin, Drug: two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)Patients in this group will receive a 14-day quadruple therapy based on personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics chosen according to medication history. If the patient hasn't been treated with levofloxacin in the previous eradication regimen, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and levofloxacin 500mg qd for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-70 with persistent Helicobacter pylori infection.
- Patients with previous Helicobacter pylori eradication therapy for one or two times.
Key exclusion criteria (6 listed)
- Patients unable or unwilling to receive gastroscopy.
- Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
- Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
- Patients with known or suspected allergy to study medications.
- Currently pregnant or lactating.
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 |
|---|---|---|
| two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)Patients will receive a 14-day quadruple therapy for the H.pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. | Drug | Antimicrobial susceptibility guided therapy |
| one proton pump inhibitor, colloidal bismuth pectinAll patients need these two drugs. | Drug | Antimicrobial susceptibility guided therapy, Empirical therapy according to medication history |
| two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)Patients will receive a 14-day quadruple therapy according to personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient hasn't been treated with levofloxacin previously, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone. | Drug | Empirical therapy according to medication history |
Primary outcome
Eradication rates
Time frame: 6 months
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
3 secondary outcomes
The rates of adverse events happening
Time frame: 6 months
The rates of improving dyspepsia symptoms after helicobacter pylori eradication.
Time frame: 6 months
The rates of good compliance.
Time frame: 6 months
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 12 May 2020.
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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.
Xiuli Zuo, MD,PhD principal investigator
Qilu Hospital of Shandong University
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 two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline), one proton pump inhibitor, colloidal bismuth pectin and two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone) in people with Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 12 May 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 China. 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?
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 rates (time frame: 6 months). 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 12 May 2020.