Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparison of Susceptibility Testing Guided Versus Empirical Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332848
• Other study ID #: 202001085MINB
• Status: Recruiting
• Phase: Phase 4
• Start date: July 24, 2020
• Est. completion date: March 2023

Study information

• Verified date: January 2021
• Source: National Taiwan University Hospital
• Contact: Mei-Jyh Chen
• Phone: 886-2-23123456
• Email: migichen[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: Therefore, we aimed to

1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection

2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors.

Methods: This will be a multi-center, open labeled trial

Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori:

Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics.

Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy

Outcome Measurement:

Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses.

Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion criteria

• Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.

Related Conditions & MeSH terms

• Disease Susceptibility
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• ET
Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple therapy or concomitant therapy
• SGT
Susceptibility testing guided therapy Based on susceptibility test: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple therapy or concomitant therapy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the eradication rate in the third treatment according to intention-to treat (ITT) analysis.	Eradication rate will be determined by urea breath test at least 6 weeks after completion of treatment.	6 weeks
Secondary	Adverse effects	A standard interview and questionaire will be used to assess the adverse effects.	2 weeks