The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: H. Pylori Infection
Intervention: Cravit-based sequential therapy (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: National Taiwan University Hospital Overall contact:
Jyh-Ming Liou, MD, Phone: 886-2-23123456, Ext: 63541, Email: dtmed046@pchome.com.tw
Summary
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.
Clinical Details
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jyh-Ming Liou, MD, Phone: 886-2-23123456, Ext: 63541, Email: dtmed046@pchome.com.tw
National Taiwan University Hospital, Taipei 10002, Taiwan
Additional Information
Starting date: April 2009
Ending date: April 2010
Last updated: April 21, 2009
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