Antimicrobial Susceptibility TestingPhase 4NCT03139253
Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment
A Phase 4 study testing amoxicillin, clarithromycin and tinidazole in people with Antimicrobial Susceptibility Testing and Triple Therapy, run by Yanqing Li.
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
- Antimicrobial Susceptibility Testing, Triple Therapy
- What is being tested?
- amoxicillin, clarithromycin and tinidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2017to 30 Jun 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
No sites are listed yet.
About this study
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
- amoxicillin, clarithromycin, tinidazole, levofloxacin, furazolidone
- Keywords
- Helicobacter Pylori Infection, Antimicrobial susceptibility testing (AST), Triple Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillinDrug
amoxicillin 1000 mg bid. for 14 days
clarithromycinDrug
clarithromycin 500 mg bid. for 14 days.
tinidazoleDrug
tinidazole 500 mg bid. for 14 days.
levofloxacinDrug
levofloxacin 500 mg qd. for 14 days.
furazolidoneDrug
furazolidone 100 mg bid. for 14 days.
tetracyclineDrug
tetracycline 750 mg bid. for 14 days.
IlaprazoleDrug
Ilaprazole 5 mg bid. for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| clarithromycin susceptible | Experimental | Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin.
Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). Receives: Drug: amoxicillin; Drug: clarithromycin; Drug: Ilaprazole |
| metronidazole susceptible | Experimental | Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole. Receives: Drug: amoxicillin; Drug: tinidazole; Drug: Ilaprazole |
| levofloxacin susceptible | Experimental | Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin. Receives: Drug: amoxicillin; Drug: levofloxacin; Drug: Ilaprazole |
| furazolidone susceptible | Experimental | Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone. Receives: Drug: amoxicillin; Drug: furazolidone; Drug: Ilaprazole |
| tetracycline susceptible | Experimental | Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline. Receives: Drug: amoxicillin; Drug: tetracycline; Drug: Ilaprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of AST guided triple therapy
Measured: 3 months
Secondary outcomes (3)
the rate of improving dyspepsia symptoms after H. pylori eradication
Measured: 3 months
the rate of adverse events happening
Measured: 3 months
the rate of good compliance (take pills more than 90%)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start30 May 2017 (estimated)
- Primary completion30 Jun 2017 (estimated)
- Study completion30 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial Susceptibility TestingStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139253
- Sponsor's protocol ID
- 2017SDU-QILU-02
- Status last verified
- May 2017
- First submitted
- 23 Apr 2017
- Last updated
- 3 May 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 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment
- ClinicalTrials.gov ID
- NCT03139253
- Acronym / sponsor ID
- 2017SDU-QILU-02
- Keywords
- Helicobacter Pylori Infection, Antimicrobial susceptibility testing (AST), Triple Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Study start
- 30 May 2017 (estimated)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 30 Jun 2017 (estimated)
- First posted
- 3 May 2017 (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.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| clarithromycin susceptible | Experimental | Drug: amoxicillin, Drug: clarithromycin, Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). |
| metronidazole susceptible | Experimental | Drug: amoxicillin, Drug: tinidazole, Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole. |
| levofloxacin susceptible | Experimental | Drug: amoxicillin, Drug: levofloxacin, Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin. |
| furazolidone susceptible | Experimental | Drug: amoxicillin, Drug: furazolidone, Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone. |
| tetracycline susceptible | Experimental | Drug: amoxicillin, Drug: tetracycline, Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline. |
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 |
|---|---|---|
| amoxicillinamoxicillin 1000 mg bid. for 14 days | Drug | clarithromycin susceptible, furazolidone susceptible, levofloxacin susceptible, metronidazole susceptible, tetracycline susceptible |
| clarithromycinclarithromycin 500 mg bid. for 14 days. | Drug | clarithromycin susceptible |
| tinidazoletinidazole 500 mg bid. for 14 days. | Drug | metronidazole susceptible |
| levofloxacinlevofloxacin 500 mg qd. for 14 days. | Drug | levofloxacin susceptible |
| furazolidonefurazolidone 100 mg bid. for 14 days. | Drug | furazolidone susceptible |
| tetracyclinetetracycline 750 mg bid. for 14 days. | Drug | tetracycline susceptible |
| IlaprazoleIlaprazole 5 mg bid. for 14 days. | Drug | clarithromycin susceptible, furazolidone susceptible, levofloxacin susceptible, metronidazole susceptible, tetracycline susceptible |
Primary outcome
Eradication rate of AST guided triple therapy
Time frame: 3 months
3 secondary outcomes
the rate of improving dyspepsia symptoms after H. pylori eradication
Time frame: 3 months
the rate of adverse events happening
Time frame: 3 months
the rate of good compliance (take pills more than 90%)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amoxicillin, clarithromycin and tinidazole in people with Antimicrobial Susceptibility Testing and Triple Therapy, run by Yanqing Li.
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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 rate of AST guided triple therapy (time frame: 3 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 3 May 2017.