NCT05549115

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

September 18, 2022

Last Update Submit

December 11, 2023

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriDrug Resistance, MicrobialMicrobial Sensitivity Tests

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • the rescue H. pylori eradication rate

    4-8 weeks after the second treatment

  • the overall H.pylori eradication rate

    4-8 weeks after the second treatment

  • high-dose dual therapy eradication rate

    4-8 weeks after the second treatment

  • Adverse events and compliance

    3 days after the end of treatment.

Study Arms (6)

clarithromycin-sensitive(first-line)

EXPERIMENTAL

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

Drug: clarithromycin-sensitive(first-line)

clarithromycin-resistant(first-line)

EXPERIMENTAL

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.

Drug: clarithromycin-resistant(first-line)

empirical therapy group first-line

ACTIVE COMPARATOR

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.

Drug: empirical therapy group first-line

levofloxacin-sensitive(rescue treatment)

EXPERIMENTAL

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.

Drug: levofloxacin-sensitive(rescue treatment)

levofloxacin-resistant(rescue treatment)

EXPERIMENTAL

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.

Drug: levofloxacin-resistant(rescue treatment)

empirical therapy group rescue treatment

ACTIVE COMPARATOR

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.

Drug: empirical therapy group rescue treatment

Interventions

clarithromycin-sensitive(first-line)DRUG

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

Also known as: clarithromycin triple therapy
clarithromycin-sensitive(first-line)
clarithromycin-resistant(first-line)DRUG

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

Also known as: High-dose PPI-amoxicillin dual therapy
clarithromycin-resistant(first-line)
empirical therapy group first-lineDRUG

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

Also known as: Bismuth-containing quadruple therapy
empirical therapy group first-line
levofloxacin-sensitive(rescue treatment)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

Also known as: levofloxacin quadruple regimen
levofloxacin-sensitive(rescue treatment)
levofloxacin-resistant(rescue treatment)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

Also known as: furazolidone quadruple regimen
levofloxacin-resistant(rescue treatment)
empirical therapy group rescue treatmentDRUG

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

Also known as: High-dose PPI-amoxicillin dual therapy
empirical therapy group rescue treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaocheng people's hospital

Liaocheng, Shandong, 252000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37337241DERIVED

Study Officials

  • Jing run Zhao, Dr

    Liaocheng People's Hospital

    STUDY CHAIR

Central Study Contacts

Jing run Zhao, Dr

CONTACT

+86-635-8276373zhjrun77@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2022

First Posted

September 22, 2022

Study Start

September 20, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

December 12, 2023

Record last verified: 2022-12

Locations

CN(1)