CompletedPhase 4ACTRN12615000493549

Cure rate and side effects comparison between the sequential bismuth based quadruple therapy and the concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.

Efficacy of sequential bismuth based quadruple therapy versus concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.


Sponsor

University of Western Australia

Enrollment

200 participants

Start Date

Jan 18, 2012

Study Type

Interventional

Conditions

Summary

The primary aim of this study is to determine Efficacy of sequential bismuth based quadruple therapy versus concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • Patients must fail more than one standard triple therapy, which indicate carrying antibiotic resistant H. pylori strain.
  • If antibiotic sensitivity testing was performed, the strain must be sensitive to Ciprofloxacin and Rifabutin.

Exclusion Criteria1

  • free of H. pylori infection, mental disability, pregnancy or lactation in women, known allergy or hypersensitivity to drugs used in study therapy, or current participation with other clinical trials.

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Interventions

sequential treatment (5 days of rabeprazole 20 mg three times a day and bismuth subcitrate (BIS) 240mg four times a day, followed by 5 days of rabeprazole 20 mg three times a day, BIS 240mg four times

sequential treatment (5 days of rabeprazole 20 mg three times a day and bismuth subcitrate (BIS) 240mg four times a day, followed by 5 days of rabeprazole 20 mg three times a day, BIS 240mg four times a day, rifabutin (RFB) 150 mg twice a day and ciprofloxacin (CIP) 500 mg twice a day.); All drugs are to be taken orally; Patients compliance was checked via phone interview.


Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12615000493549