MedDataX Logo

Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection

NCT ID: NCT05549115

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-20

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Helicobacter pylori Drug Resistance, Microbial Microbial Sensitivity Tests

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

clarithromycin-sensitive(first-line)

Intervention Type DRUG

esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days

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.

Group Type EXPERIMENTAL

clarithromycin-resistant(first-line)

Intervention Type DRUG

esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days

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.

Group Type ACTIVE_COMPARATOR

empirical therapy group first-line

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

levofloxacin-sensitive(rescue treatment)

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

levofloxacin-resistant(rescue treatment)

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

empirical therapy group rescue treatment

Intervention Type DRUG

esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

clarithromycin-sensitive(first-line)

esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days

Intervention Type DRUG

clarithromycin-resistant(first-line)

esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days

Intervention Type DRUG

empirical therapy group first-line

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

Intervention Type DRUG

levofloxacin-sensitive(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

Intervention Type DRUG

levofloxacin-resistant(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

Intervention Type DRUG

empirical therapy group rescue treatment

esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

clarithromycin triple therapy High-dose PPI-amoxicillin dual therapy Bismuth-containing quadruple therapy levofloxacin quadruple regimen furazolidone quadruple regimen High-dose PPI-amoxicillin dual therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Liaocheng People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jing run Zhao, Dr

Role: STUDY_CHAIR

Liaocheng People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Liaocheng people's hospital

Liaocheng, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jing run Zhao, Dr

Role: CONTACT

Phone: +86-635-8276373

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jingrun Zhao, Dr

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Lu K, Lang C, Zou X, Zang L, Sang W, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-guided sequential strategy versus empirical therapy for Helicobacter pylori infection: study protocol for a randomised controlled trial. Trials. 2023 Jun 19;24(1):413. doi: 10.1186/s13063-023-07457-z.

Reference Type DERIVED
PMID: 37337241 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CS-HP001

Identifier Type: -

Identifier Source: org_study_id