Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Self Efficacy

Treatments: Drug: empirical therapy; Drug: Genotypic resistance guided therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01725906

201202068MIC

Details and patient eligibility

About

We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.

Full description

The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).

Enrollment: 450 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.

Exclusion criteria

• Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

450 participants in 2 patient groups

Empirical therapy

Active Comparator group

Description:

selection of antibiotic according to medication history

Treatment:

Drug: empirical therapy

Genotypic resistance guided therapy

Experimental group

Description:

selection of antibiotics according to genotypic resistance

Treatment:

Drug: Genotypic resistance guided therapy