Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

Self Efficacy Clinical Trial

Official title:

Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01725906
• Other study ID #: 201202068MIC
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2012
• Last updated: May 4, 2017
• Start date: November 2012
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: National Taiwan University Hospital
• Contact: Jyh-Ming Liou, MD
• Phone: +886223123456
• Email: dtmed046[@]pchome.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Self Efficacy

Intervention

Drug:
• empirical therapy
Nexium (esomeprazole), 40mg, bid, 14 days, plus Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 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
• Genotypic resistance guided therapy
Nexium (esomeprazole), 40mg, bid, 14 days, plus Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 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

Locations

Country	Name	City	State
Taiwan	National Taiwan Universtiy Hospital	Taipei
Taiwan	National Taiwan University Hospital, Yun-Lin Branch	Yun-Lin County

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate after third line rescue therapy	Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses.; (genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status	8 weeks
Secondary	eradication rates in subgroup analysis by antibiotic resistance and regimen	eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen	8 weeks