Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

February 2, 2015 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Prospective, Randomized Controlled Trial Comparing Amoxicillin and Metronidazole Based Bismuth-containing Quadruple Therapy With Amoxicillin and Clarithromycin Based Quadruple Therapy for First-line Helicobacter Pylori Eradication

No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple regiment for Helicobacter pylori eradication.

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. It is a common and potentially curable cause of dyspepsia and peptic ulcer disease. Eradication in patients with peptic ulcer or even functional or non-investigated dyspepsia is a cost effective approach.

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. Due to the low efficacy achieved with these treatments, they have been deemed as unethical comparators in clinical trials. As antimicrobial resistance becomes more prevalent worldwide, treatment failure rates are likely to continue increasing, suggesting that new regimens for H pylori eradication must be sought.

Bismuth-containing quadruple therapies have been used widely in H. pylori therapy with many permutations of doses and durations and with variable results. Classical bismuth-based quadruple therapy containing a PPI, bismuth, tetracycline and metronidazole has been recommended as the first-line treatment by the Maastricht IV Consensus Conference report and H. pylori Study Group of Chinese Society of Gastroenterology. But this regiment has high rate of side effects because of tetracycline. Standard triple therapy-based, bismuth-containing quadruple Therapy is also an alternative. Though addition bismuth and prolonging treatment duration can overcome H. pylori resistance to clarithromycin, its use as a first-line treatment is limited in areas of high clarithromycin resistance.

Amoxicillin has low resistance rate as well as low percentage of side effects. The combination of amoxicillin and metronidazole in bismuth-containing quadruple therapy may be a better choice, which can avoid clarithromycin resistance and reduce side effects. Therefore, we will do a randomized trial to compare the eradication rate of 14-day amoxicillin and metronidazole based bismuth-containing quadruple therapy with amoxicillin and clarithromycin based quadruple therapy for Helicobacter pylori infection.

Study Type

Interventional

Enrollment (Actual)

215

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:

  • Participants with non-investigated/functional dyspepsia or scarred peptic ulcer with indication of H pylori eradication treatment
  • Ability and willingness to participate in the study and to sign and give informed consent
  • confirmed H pylori infection by at least one of the following methods: C13-urea breath test, histology, rapid urease test or bacterial culture.

Exclusion Criteria:

  • patients with peptic ulcer
  • previous H. pylori eradication therapy
  • Age below 18 years
  • major systemic diseases
  • previous gastric surgery
  • pregnancy or breastfeeding
  • allergy to any of the study drugs
  • receipt of anti-secretory therapy, antibiotics or bismuth salts 4 weeks prior to inclusion

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Amoxicillin/metronidazole
Amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, 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: Amoxicillin
antibiotic of each quadruple therapy
Other Names:
  • antibiotic
Drug: Metronidazole
antibiotic of the amoxicillin/metronidazole-based quadruple therapy
Other Names:
  • antibiotic
ACTIVE_COMPARATOR: Amoxicillin/clarithromycin
Amoxicillin/clarithromycin-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
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: Amoxicillin
antibiotic of each quadruple therapy
Other Names:
  • antibiotic
Drug: Clarithromycin
antibiotic of the amoxicillin/clarithromycin-based 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, clarithromycin, 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)

January 1, 2015

Study Completion (ACTUAL)

January 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)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjkls2014006

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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