Therapeutic DurationPhase 4NCT02934048
Optimal Duration of Antimicrobial Susceptibility Test (AST) Guided Rescue Therapy for Helicobacter Pylori Infection
A Phase 4 study testing 7-day triple regimen guided by AST, 10-day triple regimen guided by AST and 14-day triple regimen guided by AST in people with Therapeutic Duration and Helicobacter Pylori, run by Shandong University.
Trial summary
Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies. However, due to the increasing resistance rates to antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy for persistent H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapeutic Duration, Helicobacter Pylori, Antimicrobial Susceptibility Test
- What is being tested?
- 7-day triple regimen guided by AST, 10-day triple regimen guided by AST and 14-day triple regimen guided by AST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients require upper endoscopy owing to persistent H. pylori infection despite one or more treatment attempts.
Who cannot join
- Age younger than 18 years;
- Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- Known or suspected allergy to study medications;
- 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
Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies. However, due to the increasing resistance rates to antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy for persistent H. pylori infection is becoming a grand challenge the investigators have to face.
- Being tested
- 7-day triple regimen guided by AST, 10-day triple regimen guided by AST, 14-day triple regimen guided by AST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day triple regimen guided by ASTOther
Patients in this group will receive a 7-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
10-day triple regimen guided by ASTOther
Patients in this group will receive a 10-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
14-day triple regimen guided by ASTOther
Patients in this group will receive a 14-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| 7-day triple regimen | Experimental | Patients in this group received a 7-day triple regimen to eradicate H. pylori. The triple therapy contains proton pump inhibitor (PPI)-clarithromycin plus a susceptible antibiotics will be involved in the study. Receives: Other: 7-day triple regimen guided by AST |
| 10-day triple regimen | Experimental | Patients in this group received a 10-day triple regimen to eradicate H. pylori. The triple therapy contains PPI-clarithromycin plus a susceptible antibiotics will be involved in the study. Receives: Other: 10-day triple regimen guided by AST |
| 14-day triple regimen | Experimental | Patients in this group received a 14-day triple regimen to eradicate H. pylori. The triple therapy contains PPI-clarithromycin plus a susceptible antibiotics will be involved in the study. Receives: Other: 14-day triple regimen guided by AST |
What is being measured
The primary outcome is the main question the study is designed to answer.
The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in intention-to-treat (ITT) analysis.
Measured: 9 months
The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in per-protocol (PP) analysis.
Measured: 9 months
Secondary outcomes (2)
the rate of improving dyspepsia symptoms after H. pylori eradication
Measured: 9 months
the rate of adverse events happening
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic DurationStudies 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- 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
- NCT02934048
- Sponsor's protocol ID
- 2016SDU-QILU-16
- Status last verified
- Oct 2016
- First submitted
- 9 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Antimicrobial Susceptibility Test (AST) Guided Rescue Therapy for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT02934048
- Acronym / sponsor ID
- 2016SDU-QILU-16
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Oct 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.
Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies. However, due to the increasing resistance rates to antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy for persistent H. pylori infection is becoming a grand challenge the investigators have to face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7-day triple regimen | Experimental | Other: 7-day triple regimen guided by ASTPatients in this group received a 7-day triple regimen to eradicate H. pylori. The triple therapy contains proton pump inhibitor (PPI)-clarithromycin plus a susceptible antibiotics will be involved in the study. |
| 10-day triple regimen | Experimental | Other: 10-day triple regimen guided by ASTPatients in this group received a 10-day triple regimen to eradicate H. pylori. The triple therapy contains PPI-clarithromycin plus a susceptible antibiotics will be involved in the study. |
| 14-day triple regimen | Experimental | Other: 14-day triple regimen guided by ASTPatients in this group received a 14-day triple regimen to eradicate H. pylori. The triple therapy contains PPI-clarithromycin plus a susceptible antibiotics will be involved in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients require upper endoscopy owing to persistent H. pylori infection despite one or more treatment attempts.
Key exclusion criteria (4 listed)
- Age younger than 18 years;
- Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- Known or suspected allergy to study medications;
- Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
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 |
|---|---|---|
| 7-day triple regimen guided by ASTPatients in this group will receive a 7-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. | Other | 7-day triple regimen |
| 10-day triple regimen guided by ASTPatients in this group will receive a 10-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. | Other | 10-day triple regimen |
| 14-day triple regimen guided by ASTPatients in this group will receive a 14-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. | Other | 14-day triple regimen |
Primary outcome
The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in intention-to-treat (ITT) analysis.
Time frame: 9 months
The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in per-protocol (PP) analysis.
Time frame: 9 months
2 secondary outcomes
the rate of improving dyspepsia symptoms after H. pylori eradication
Time frame: 9 months
the rate of adverse events happening
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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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 7-day triple regimen guided by AST, 10-day triple regimen guided by AST and 14-day triple regimen guided by AST in people with Therapeutic Duration and Helicobacter Pylori, run by Shandong University.
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 4 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 14 Oct 2016. 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?
The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in intention-to-treat (ITT) analysis. (time frame: 9 months). The study lists 2 primary outcomes in all. 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 14 Oct 2016.