Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test

Yonsei University Health System (YUHS)

Status: Unknown

Conditions: Helicobacter Pylori Infection

Treatments: Drug: eradication of Helicobacter pylori

Study type: Interventional

Funder types: Other

Identifiers

NCT02759029

3-2015-0193

Details and patient eligibility

About

Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy are declining, and an alternative strategy is needed urgently. The investigators sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a region with high rates of multiple drug resistance.

Enrollment: 123 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. positive results of rapid urease test

Exclusion criteria

1. liver cirrhosis,
2. chronic kidney disease,
3. bleeding tendency,
4. pregnant,
5. allergy to antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 3 patient groups

Susceptibility-guided group

Active Comparator group

Description:

Drugs according to antimicrobial susceptibility-guided treatment

Treatment:

Drug: eradication of Helicobacter pylori

triple therapy group

Sham Comparator group

Description:

Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk

Treatment:

Drug: eradication of Helicobacter pylori

concomitant therapy group

Sham Comparator group

Description:

Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk

Treatment:

Drug: eradication of Helicobacter pylori