Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549115
• Other study ID #: CS-HP001
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: February 2024

Study information

• Verified date: December 2022
• Source: Liaocheng People's Hospital
• Contact: Jing run Zhao, Dr
• Phone: +86-635-8276373
• Email: zhjrun77[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• clarithromycin-sensitive(first-line)
esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
• clarithromycin-resistant(first-line)
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
• 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
• 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
• 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
• empirical therapy group rescue treatment
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days

Locations

Country	Name	City	State
China	Liaocheng people's hospital	Liaocheng	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Liaocheng People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the first-line H. pylori eradication rate	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	the rescue H. pylori eradication rate	The second line eradication rate between SGT and ET group.	4-8 weeks after the second treatment
Secondary	the overall H.pylori eradication rate	the total H.pylori eradication rate (first-line and second-line)between SGT and ET group.	4-8 weeks after the second treatment
Secondary	high-dose dual therapy eradication rate	compare H. pylori eradication rate between clarithromycin resistance group and empirical BQT failure group.	4-8 weeks after the second treatment
Secondary	Adverse events and compliance	3 days after the completion of therapy according to a data collection form	3 days after the end of treatment.