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

National Taiwan University

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: ET; Drug: SGT

Study type: Interventional

Funder types: Other

Identifiers

NCT04332848

202001085MINB

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

(B) Empirical therapy

Experimental group

Description:

choose antibiotics according to drug history

Treatment:

Drug: ET

(A) Susceptibility testing guided therapy

Active Comparator group

Description:

choose antibiotics according to susceptibility testing

Treatment:

Drug: SGT