NCT01725906

Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Self Efficacy

Interventions

Type	Name	Description
DRUG	empirical therapy	1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
DRUG	Genotypic resistance guided therapy	1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2012-11-14
• Last updated: 2017-05-08

Locations

2 sites across 1 country: Taiwan