- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05549115
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
December 11, 2023 updated by: Liaocheng People's Hospital
Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection: a Randomised Controlled Trial
The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study.
For empirical therapy group(control group), Bismuth quadruple therapy will be an empirical first-line therapy, and high dose dual (proton-pump inhibitor + amoxicillin) treatment will be for rescue therapy if the first-line empirical treat failure.
For the susceptibility-guided sequential therapy group, regimens were selected based on H. pylori susceptibility to clarithromycin and levofloxacin.
The primary outcome is the first-line eradication rate in both groups, and the overall (including first- and rescue therapies) H. pylori eradication rates in both groups is one of the secondary outcomes.
The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis and per-protocol analysis.
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing run Zhao, Dr
- Phone Number: +86-635-8276373
- Email: zhjrun77@163.com
Study Locations
-
-
Shandong
-
Liaocheng, Shandong, China, 252000
- Recruiting
- Liaocheng People's hospital
-
Contact:
- Jingrun Zhao, Dr
- Phone Number: +86-635-8276373
- Email: zhjrun77@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- H. pylori infection was determined using at least one of the following tests: 13C/14C-urea breath test (UBT), stool H. pylori antigen test, rapid urease test, and histological analysis within 4 weeks.
- Patients were naïve to H. pylori treatment.
Exclusion Criteria:
- Allergy to any drug administered.
- Pregnancy and lactation.
- Major systemic diseases, such as severe cardiopulmonary or liver dysfunction.
- Complicated with active peptic ulcer disease, gastric cancer, or prior gastrectomy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: clarithromycin-sensitive(first-line)
If H. pylori is sensitive to clarithromycin, we will administer clarithromycin triple therapy-esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily)-for 14 days
|
esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
Other Names:
|
Experimental: clarithromycin-resistant(first-line)
If H. pylori is clarithromycin resistance, we selected the High-dose dual therapy (HDDT) regimen as first-line treatment.
HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used for 14 days.
|
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
Other Names:
|
Active Comparator: empirical therapy group first-line
The empirical therapy group will receive Bismuth-containing quadruple therapy(BQT) as first-line treatment, The BQT regime is comprising of esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days.
|
esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
Other Names:
|
Experimental: levofloxacin-sensitive(rescue treatment)
If H. pylori was levofloxacin-sensitive, we will use the levofloxacin quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days.
|
esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days
Other Names:
|
Experimental: levofloxacin-resistant(rescue treatment)
If H. pylori was levofloxacin-resistant, we will use furazolidone quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days.
|
esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days
Other Names:
|
Active Comparator: empirical therapy group rescue treatment
If BQT fails, HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used as a rescue treatment for 14 days.
|
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the first-line H. pylori eradication rate
Time Frame: 4-8 weeks after the end of treatment.
|
the proportion of participants with successful H. pylori eradication, as determined by 13C-Urea breath test(UBT), at least 4 weeks after the end of the first-line treatment period between Susceptibility-guided therapy(SGT) and empirical therapy(ET) group.
|
4-8 weeks after the end of treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the rescue H. pylori eradication rate
Time Frame: 4-8 weeks after the second treatment
|
The second line eradication rate between SGT and ET group.
|
4-8 weeks after the second treatment
|
the overall H.pylori eradication rate
Time Frame: 4-8 weeks after the second treatment
|
the total H.pylori eradication rate (first-line and second-line)between SGT and ET group.
|
4-8 weeks after the second treatment
|
high-dose dual therapy eradication rate
Time Frame: 4-8 weeks after the second treatment
|
compare H. pylori eradication rate between clarithromycin resistance group and empirical BQT failure group.
|
4-8 weeks after the second treatment
|
Adverse events and compliance
Time Frame: 3 days after the end of treatment.
|
3 days after the completion of therapy according to a data collection form
|
3 days after the end of treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jing run Zhao, Dr, Liaocheng People's hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2022
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
September 18, 2022
First Submitted That Met QC Criteria
September 18, 2022
First Posted (Actual)
September 22, 2022
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Infections
- Communicable Diseases
- Helicobacter Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Gastrointestinal Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Monoamine Oxidase Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Antacids
- Anti-Infective Agents, Urinary
- Antitrichomonal Agents
- Amoxicillin
- Clarithromycin
- Levofloxacin
- Ofloxacin
- Bismuth
- Furazolidone
Other Study ID Numbers
- CS-HP001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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