Helicobacter Pylori InfectionPhase 4NCT02988089
Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment
A Phase 4 study testing Clarithromycin susceptibility dependant strategy, 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ) and proton pump inhibitor (PPI) and Colloidal Bismuth Pectin in people with Helicobacter Pylori Infection and Antimicrobial Susceptibility Testing, run by Shandong University at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection, Antimicrobial Susceptibility Testing
- What is being tested?
- Clarithromycin susceptibility dependant strategy, 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ) and proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2017to Sep 2017
- 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
- Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.
Who cannot join
- Enable to undergo upper endoscopy;
- Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- Known or suspected allergy to study medications;
- Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
- 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.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Ji'nan, Shandong, 250012
Yanqing Li, MD, PhD, 86-531-82169236, liyanqing@sdu.edu.cn
Yanqing Li, MD, PhD, 86-0531-82169236, liyanqing@sdu.edu.cn
About this study
Official title: Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment
Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.
- Being tested
- Clarithromycin susceptibility dependant strategy, 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ), proton pump inhibitor (PPI) and Colloidal Bismuth Pectin, amoxicillin and clarithromycin or amoxicillin and furazolidone, amoxicillin and furazolidone or amoxicillin and tetracycline
- Keywords
- Helicobacter Pylori Infection, Antimicrobial susceptibility testing (AST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin susceptibility dependant strategyDrug
Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin.
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.
2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )Drug
Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
proton pump inhibitor (PPI) and Colloidal Bismuth PectinDrug
all patients need these two drugs.
amoxicillin and clarithromycin or amoxicillin and furazolidoneDrug
patients in the 6 antibiotics dependant group will use these intervention.
amoxicillin and furazolidone or amoxicillin and tetracyclineDrug
salvage therapy for negative culture when the results of culture are negative
amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and LevofloxacinDrug
salvage therapy for failed eradication if failed with AST guided eradication therapy
| Study group | Role | What they receive |
|---|---|---|
| clarithromycin dependant group | Experimental | Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.
The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin.
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen. Receives: Drug: Clarithromycin susceptibility dependant strategy; Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone |
| 6 antibiotics dependant group | Experimental | Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. Receives: Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ); Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin |
| salvage therapy for negative culture | Other | when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily. Receives: Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; Drug: amoxicillin and furazolidone or amoxicillin and tetracycline |
| salvage therapy for failed eradication | Other | If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d. Receives: Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rates in 2 groups
Measured: 6 months
Secondary outcomes (4)
the rate of improving dyspepsia symptoms after H. pylori eradication
Measured: 6 months
the rate of adverse events happening
Measured: 6 months
the rate of good compliance (take pills more than 90%)
Measured: 5 months
difference of cost per patient for each eradication achieved in 2 groups
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 posted9 Dec 2016 (estimated)
- Study start20 Apr 2017
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, General Hospital of Jinan Military Region, Binzhou People's Hospital, Liaocheng People's Hospital
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988089
- Sponsor's protocol ID
- 2016SDU-QILU-23
- Status last verified
- Apr 2017
- First submitted
- 4 Dec 2016
- Last updated
- 25 Apr 2017
- 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 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment
- ClinicalTrials.gov ID
- NCT02988089
- Acronym / sponsor ID
- 2016SDU-QILU-23
- Keywords
- Helicobacter Pylori Infection, Antimicrobial susceptibility testing (AST)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, General Hospital of Jinan Military Region, Binzhou People's Hospital, Liaocheng People's Hospital
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- 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.
Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| clarithromycin dependant group | Experimental | Drug: Clarithromycin susceptibility dependant strategy, Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin, Drug: amoxicillin and clarithromycin or amoxicillin and furazolidonePatients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin. If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen. |
| 6 antibiotics dependant group | Experimental | Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ), Drug: proton pump inhibitor (PPI) and Colloidal Bismuth PectinPatients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. |
| salvage therapy for negative culture | Other | Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin, Drug: amoxicillin and furazolidone or amoxicillin and tetracyclinewhen the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily. |
| salvage therapy for failed eradication | Other | Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin, Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and LevofloxacinIf failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.
Key exclusion criteria (6 listed)
- Enable to undergo upper endoscopy;
- Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- Known or suspected allergy to study medications;
- Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
- 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 |
|---|---|---|
| Clarithromycin susceptibility dependant strategyPatients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin. If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen. | Drug | clarithromycin dependant group |
| 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. | Drug | 6 antibiotics dependant group |
| proton pump inhibitor (PPI) and Colloidal Bismuth Pectinall patients need these two drugs. | Drug | 6 antibiotics dependant group, clarithromycin dependant group, salvage therapy for failed eradication, salvage therapy for negative culture |
| amoxicillin and clarithromycin or amoxicillin and furazolidonepatients in the 6 antibiotics dependant group will use these intervention. | Drug | clarithromycin dependant group |
| amoxicillin and furazolidone or amoxicillin and tetracyclinesalvage therapy for negative culture when the results of culture are negative | Drug | salvage therapy for negative culture |
| amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacinsalvage therapy for failed eradication if failed with AST guided eradication therapy | Drug | salvage therapy for failed eradication |
Primary outcome
Eradication rates in 2 groups
Time frame: 6 months
4 secondary outcomes
the rate of improving dyspepsia symptoms after H. pylori eradication
Time frame: 6 months
the rate of adverse events happening
Time frame: 6 months
the rate of good compliance (take pills more than 90%)
Time frame: 5 months
difference of cost per patient for each eradication achieved in 2 groups
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- 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.
Li Yanqing, 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 Clarithromycin susceptibility dependant strategy, 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ) and proton pump inhibitor (PPI) and Colloidal Bismuth Pectin in people with Helicobacter Pylori Infection and Antimicrobial Susceptibility Testing, 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 1 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 25 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yanqing, MD, PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rates in 2 groups (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 25 Apr 2017.