High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection

February 29, 2016 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Prospective, Randomized Controlled Trial Comparing High Dose Amoxicillin Versus Tetracycline Based Quadruple Therapy as Second-line Treatment for Resistant Helicobacter Pylori Infection

No trial has examined the the efficacy of high dose amoxicillin based quadruple therapy as second-line treatment for Helicobacter pylori infection. The study aims to compare the effectiveness and safety of 14-day high dose amoxicillin-based quadruple regiment with classical quadruple regiment for rescue eradication of Helicobacter pylori.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Helicobacter pylori is the most successful human pathogen infecting an estimated 50% of the global population, and is associated with a spectrum of disease states, including chronic gastritis, duodenal and gastric ulcer, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma (MALToma).

Most Consensus Conferences and Clinical Guidelines recommend the prescription of a triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole, as first-line treatment. However, the effectiveness of these triple-therapy regimens seems to have diminished over time, largely as a result of emerging resistance of the organism to clarithromycin. Avoiding problems due to antibiotic resistance has become an important issue when deciding a second-line rescue therapy for H. pylori infection

Bismuth-containing quadruple therapies have been used widely in second-line therapy of H. pylori infection, and are recommended by the Maastricht IV Consensus Conference report. Quadruple therapy can achieve a high rate of eradication success as a second-line treatment. A meta-analysis of quadruple therapy showed that metronidazole resistance had limited effect on the outcome when adequate dosages and durations are used. This meta-analysis also showed that compliance with quadruple therapy is high. Classical bismuth-based quadruple therapy consists of a PPI, bismuth, tetracycline and metronidazole. This regiment meets the proposed criteria for a second-line treatment: it does not contain the key antibiotic of the original regimen (clarithromycin), the treatment is not affected by clarithromycin resistance, metronidazole resistance in vitro does not affect the outcome of quadruple therapy significantly, compliance with the regimen is high and the regimen is effective in most parts of the world. But this regiment has high rate of side effects because of tetracycline.

Amoxicillin has low resistance rate as well as low percentage of side effects. The replacement of tetracycline by high dose amoxicillin in classical bismuth-containing quadruple therapy may be a better choice. Therefore, we will do a randomized trial to compare the eradication rate of 14-day high dose amoxicillin and metronidazole based bismuth-containing quadruple therapy with classical quadruple therapy for second-line Helicobacter pylori treatment.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Renji Hospital, Shanghai Jiao-Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before
  • indication of rescue H pylori eradication treatment
  • Ability and willingness to participate in the study and to sign and give informed consent

Exclusion Criteria:

  • patients less than 18 years old
  • previous gastric surgery
  • pregnancy or lactation
  • major systemic diseases,
  • administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks
  • allergy to any one of the medication used in the quadruple regimens.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose Amoxicillin
High dose amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg tid, Metronidazole 400mg qid
Drug: Lansoprazole
antisecretory drug of each quadruple therapy
Other Names:
  • proton pump inhibitor
Drug: Bismuth Potassium Citrate
one component of each quadruple therapy
Other Names:
  • Bismuth
Drug: Metronidazole
antibiotic of each quadruple therapy
Other Names:
  • antibiotic
Drug: Amoxicillin
antibiotic of high dose amoxicillin based quadruple therapy
Other Names:
  • antibiotic
Active Comparator: Tetracycline
Classical quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
Drug: Lansoprazole
antisecretory drug of each quadruple therapy
Other Names:
  • proton pump inhibitor
Drug: Bismuth Potassium Citrate
one component of each quadruple therapy
Other Names:
  • Bismuth
Drug: Metronidazole
antibiotic of each quadruple therapy
Other Names:
  • antibiotic
Drug: Tetracycline
antibiotic of classical quadruple therapy
Other Names:
  • antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate of Helicobacter pylori
Time Frame: 2 months
Access eradication rate of H. pylori by intention to treat (ITT) and per-protocol (PP) analysis in each treatment group
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of side effects of each treatment
Time Frame: 2 months
Score side effects as mild, moderate or severe according to their influence on daily activities
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal inhibitory concentrations (MIC) of antibiotics against each helicobacter pylori clinical isolate
Time Frame: 2 months
Determine MIC of amoxicillin, tetracycline, and metronidazole by the twofold agar dilution method.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjkls2014007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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