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| Sponsor: | National Taiwan University Hospital |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00885417 |
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:
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cravit-based sequential therapy: Experimental
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jyh-Ming Liou, MD | 886-2-23123456 ext 63541 | dtmed046@pchome.com.tw |
| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan, 10002 | |
More Information
| Responsible Party: | National Taiwan University Hospital ( Jyh-Ming Liou ) |
| Study ID Numbers: | 200901041M |
| Study First Received: | April 20, 2009 |
| Last Updated: | April 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00885417 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Helicobacter pylori sequential therapy levofloxacin clarithromycin |
rescue salvage treatment failure For those who fail from one standard eradication therapy for H. pylori infection |
|
Communicable Diseases Infection |