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

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: SGT; Drug: ET

• Registration Number: NCT04332848
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-03
• Study Start: 2020-07-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(A) Susceptibility testing guided therapy	SGT	choose antibiotics according to susceptibility testing
(B) Empirical therapy	ET	choose antibiotics according to drug history

Primary Outcome Measures

Name	Time	Method
The primary outcome is the eradication rate in the third treatment according to intention-to treat (ITT) analysis.	6 weeks	Eradication rate will be determined by urea breath test at least 6 weeks after completion of treatment.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	2 weeks	A standard interview and questionaire will be used to assess the adverse effects.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan