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

ConditionHelicobacter Pylori Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-90
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • ET

    Drug

    Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple/quadruple therapy or concomitant therapy

  • SGT

    Drug

    Susceptibility testing guided therapy Based on susceptibility test: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple/quadruple therapy or concomitant therapy

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: (B) Empirical therapyExperimental treatment 1 intervention
Group B: (A) Susceptibility testing guided therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks

Secondary outcomes

1

Adverse effects

A standard interview and questionaire will be used to assess the adverse effects.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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