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Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

Primary Purpose

Dyspepsia, Peptic Ulcer

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lansoprazole
Bismuth Potassium Citrate
Amoxicillin
Metronidazole
Clarithromycin
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring helicobacter pylori eradication, antibiotic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amoxicillin/metronidazole

Amoxicillin/clarithromycin

Arm Description

Amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, Metronidazole 400mg qid

Amoxicillin/clarithromycin-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid

Outcomes

Primary Outcome Measures

Eradication rate of Helicobacter pylori
Access eradication rate of H. pylori by intention to treat (ITT) and per-protocol (PP) analysis in each treatment group

Secondary Outcome Measures

Frequency of side effects of each treatment
Score side effects as mild, moderate or severe according to their influence on daily activities

Full Information

First Posted
June 24, 2014
Last Updated
February 2, 2015
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02175901
Brief Title
Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Peptic Ulcer
Keywords
helicobacter pylori eradication, antibiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin/metronidazole
Arm Type
Experimental
Arm Description
Amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, Metronidazole 400mg qid
Arm Title
Amoxicillin/clarithromycin
Arm Type
Active Comparator
Arm Description
Amoxicillin/clarithromycin-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
proton pump inhibitor
Intervention Description
antisecretory drug of each quadruple therapy
Intervention Type
Drug
Intervention Name(s)
Bismuth Potassium Citrate
Other Intervention Name(s)
Bismuth
Intervention Description
one component of each quadruple therapy
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
antibiotic
Intervention Description
antibiotic of each quadruple therapy
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
antibiotic
Intervention Description
antibiotic of the amoxicillin/metronidazole-based quadruple therapy
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Other Intervention Name(s)
antibiotic
Intervention Description
antibiotic of the amoxicillin/clarithromycin-based quadruple therapy
Primary Outcome Measure Information:
Title
Eradication rate of Helicobacter pylori
Description
Access eradication rate of H. pylori by intention to treat (ITT) and per-protocol (PP) analysis in each treatment group
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Frequency of side effects of each treatment
Description
Score side effects as mild, moderate or severe according to their influence on daily activities
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Minimal inhibitory concentrations (MIC) of antibiotics against each helicobacter pylori clinical isolate
Description
Determine MIC of amoxicillin, clarithromycin, and metronidazole by the twofold agar dilution method.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Lu, M.D.
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Renji Hospital, Shanghai Jiao-Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22491499
Citation
Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
Results Reference
background
PubMed Identifier
20557366
Citation
Sun Q, Liang X, Zheng Q, Liu W, Xiao S, Gu W, Lu H. High efficacy of 14-day triple therapy-based, bismuth-containing quadruple therapy for initial Helicobacter pylori eradication. Helicobacter. 2010 Jun;15(3):233-8. doi: 10.1111/j.1523-5378.2010.00758.x.
Results Reference
background
PubMed Identifier
23778309
Citation
Lu H, Zhang W, Graham DY. Bismuth-containing quadruple therapy for Helicobacter pylori: lessons from China. Eur J Gastroenterol Hepatol. 2013 Oct;25(10):1134-40. doi: 10.1097/MEG.0b013e3283633b57.
Results Reference
background
PubMed Identifier
26338726
Citation
Zhang W, Chen Q, Liang X, Liu W, Xiao S, Graham DY, Lu H. Bismuth, lansoprazole, amoxicillin and metronidazole or clarithromycin as first-line Helicobacter pylori therapy. Gut. 2015 Nov;64(11):1715-20. doi: 10.1136/gutjnl-2015-309900. Epub 2015 Sep 2.
Results Reference
derived

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Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

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