Skip to content

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00885417
Enrollment
142
Registered
2009-04-22
Start date
2009-04-30
Completion date
2010-12-31
Last updated
2011-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H. Pylori Infection

Keywords

Helicobacter pylori, sequential therapy, levofloxacin, clarithromycin, rescue, salvage, treatment failure, For those who fail from one standard eradication therapy for H. pylori infection

Brief 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.

Interventions

DRUGCravit-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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses2009/4/20

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026