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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
History of Changes
  Purpose

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.


Condition Intervention Phase
H. Pylori Infection
 Drug: Cravit-based sequential therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 142
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885417

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jyh-Ming Liou, MD Nationa Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Jyh-Ming Liou, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00885417     History of Changes
Other Study ID Numbers: 200901041M
Study First Received: April 20, 2009
Last Updated: April 21, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Helicobacter pylori
sequential therapy
levofloxacin
clarithromycin
 rescue
salvage
treatment failure
For those who fail from one standard eradication therapy for H. pylori infection

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Ofloxacin
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013