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The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00885417
First received: April 20, 2009
Last updated: April 21, 2011
Last verified: March 2011

April 20, 2009
April 21, 2011
April 2009
December 2010   (final data collection date for primary outcome measure)
Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses [ Time Frame: 2009/4/20 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00885417 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study
The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study

Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. The commonly used salvage regimens include:

  1. Bismuth based quadruple therapy (combined with ranitidine or proton-pump inhibitor (PPI) plus two antibiotics)
  2. Levofloxacin or moxifloxacin or rifabutin based triple therapy.

However, Bismuth is not available in many countries and the administration method is complex. Its usage is limited by the high pill number and low compliance rate. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and metronidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%.

Aims: Therefore, the investigators aim to assess the efficacy of levofloxacin-based sequential therapy as second line therapy for those who fail from one standard eradication therapy.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
H. Pylori Infection
Drug: Cravit-based sequential therapy
Eligible patients will be treated with (esomeprazole 40mg bid +amoxicillin 1gm bid) for 5 days, followed by (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid ) for another 5 days
Experimental: Cravit-based sequential therapy
Cravit-based sequential therapy Eligible patients will be treated with (esomeprazole 40mg bid +amoxicillin 1gm bid) for 5 days, followed by (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid ) for another 5 days
Intervention: Drug: Cravit-based sequential therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients are aged greater than 20 years who have persistent H. pylori infection after one treatment and are willing to receive second line rescue regimens, respectively, are considered eligible for enrollment.

Exclusion Criteria:

  • Children and teenagers aged less than 20 years,
  • History of gastrectomy,
  • Gastric malignancy, including adenocarcinoma and lymphoma,
  • Previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin) and prompt pump inhibitors (esomeprazole),
  • Contraindication to treatment drugs,
  • Pregnant or lactating women, OR
  • Severe concurrent disease.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00885417
200901041M
Yes
Jyh-Ming Liou, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Jyh-Ming Liou, MD Nationa Taiwan University Hospital
National Taiwan University Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP