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The Efficacy of Susceptibility Test -Driven Sequential Therapy as the Third Line Therapy for Refractory Helicobacter Pylori Infection

2014-07-23 21:11:22 | BioPortfolio

Summary

Background: 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 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%. According to the Maastricht III consensus meeting, it was recommended that susceptibility test should be done for patients who failed two treatments. Therefore, we aimed to assess the efficacy of susceptibility test driven sequential therapy as the third line therapy for those who fail from two standard eradication therapies.

Methods: This will be a multi-center, open labeled pilot study

1. Patients:

- Open labeled, non-comparative pilot study

- About 30 H. pylori infected patients who fail from two standard therapy will be enrolled

2. Testing for H. pylori infection:

- Before salvage treatment:

either (1) any two positive of CLO test, histology, and culture or (2) a positive C13-UBT will be considered as failure of previous eradication treatment EGD with gastric biopsy will be done for H. pylori culture and susceptibility test

- After salvage treatment: C13-UBT will be used to assess the existence of H. pylori after 2nd or 3rd line salvage therapy

3. Treatment regimens and assignment:

- D1-7: Nexium (40 mg, bid), Amolin (1 gm, bid)

- D8-14: Nexium (40 mg, bid), Flagyl (500 mg, bid) plus either one of the following according to antibiotic susceptibility test (1) Klaricid, 500 mg, bid or (2) Cravit, 250 mg, bid or (3) Tetracycline, 500 mg, bid

4. Outcome Measurement:

- Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses

- Secondary End Point: the eradication rate according to antibiotic susceptibility before salvage therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Helicobacter Pylori Infection

Intervention

susceptibility test guided sequential therapy

Location

National Taiwan University Hospital
Taipei
Taiwan
10002

Status

Recruiting

Source

National Taiwan University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:22-0400

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Medical and Biotech [MESH] Definitions

Infections with organisms of the genus HELICOBACTER, particularly, in humans, HELICOBACTER PYLORI. The clinical manifestations are focused in the stomach, usually the gastric mucosa and antrum, and the upper duodenum. This infection plays a major role in the pathogenesis of type B gastritis and peptic ulcer disease.

A spiral bacterium active as a human gastric pathogen. It is a gram-negative, urease-positive, curved or slightly spiral organism initially isolated in 1982 from patients with lesions of gastritis or peptic ulcers in Western Australia. Helicobacter pylori was originally classified in the genus CAMPYLOBACTER, but RNA sequencing, cellular fatty acid profiles, growth patterns, and other taxonomic characteristics indicate that the micro-organism should be included in the genus HELICOBACTER. It has been officially transferred to Helicobacter gen. nov. (see Int J Syst Bacteriol 1989 Oct;39(4):297-405).

A species of gram-negative, spiral-shaped bacteria found in the gastric mucosa that is associated with chronic antral gastritis. This bacterium was first discovered in samples removed at endoscopy from patients investigated for HELICOBACTER PYLORI colonization.

Ulceration of the GASTRIC MUCOSA due to contact with GASTRIC JUICE. It is often associated with HELICOBACTER PYLORI infection or consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).

Method of measuring the bactericidal activity contained in a patient's serum as a result of antimicrobial therapy. It is used to monitor the therapy in BACTERIAL ENDOCARDITIS; OSTEOMYELITIS and other serious bacterial infections. As commonly performed, the test is a variation of the broth dilution test. This test needs to be distinguished from testing of the naturally occurring BLOOD BACTERICIDAL ACTIVITY.

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