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

NCT00885417 | Completed Phase 4 DMC

• 1 other identifier: 200901041M
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses

  2009/4/20

Study Arms (1)

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

Interventions

Cravit-based sequential therapy DRUG

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

Cravit-based sequential therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Study Officials

• Jyh-Ming Liou, MD

  Nationa Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 22, 2011

Record last verified: 2011-03

Locations

TW (1)