A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Using Clarithromycin
1 other identifier
interventional
672
1 country
1
Brief Summary
As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed 70% in China，and had to drop out of the first-line treatment recommendations. However, with the increase of treatment time, patients burden, adverse reactions of antibiotics or proton pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of the failure to eradicate Helicobacter pylori. But, in terms of population, there are still more than 70% of the patients with clarithromycin sensitive. Under the guidance with susceptibility test，7-day standard triple therapy could be used. In this study, investigators will select the patients with infection of H. pylori and with clarithromycin sensitive. Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10 days and 14 days groups. Then, investigators will perform a sequencing for failed treatment patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally, investigators will compare the differences between the patients with triple therapy and traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per person.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 19, 2019
August 1, 2018
2.9 years
August 23, 2016
February 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The accurate determination of clarithromycin susceptibility.
Assess bacterial susceptibility to antibiotics using the agar diffusion method. The Resistance point of clarithromycin was divided into 0.125μg/ml,0.25μg/ml,0.5μg/ml and 1μg/ml.Test clarithromycin resistance of Helicobacter pylori for patients.
2 years
Establish individualized precision triple therapy based on minimal inhibitory concentration.
Based on the clarithromycin accurate susceptibility，pinpoint different courses of triple treatment therapy targeted to different people based on minimal inhibitory concentration of clarithromycin.
2.5 years
Secondary Outcomes (1)
The incidence of adverse effects
3 years
Other Outcomes (1)
Impact of mixed infection and CYP2C19 genotype on eradication rate for Helicobacter pylori with triple therapy using clarithromycin.
3 years
Study Arms (7)
Clarithromycin resistance group
EXPERIMENTALPatients who are resistant to clarithromycin in susceptibility test were classified into clarithromycin resistance group.
7 days Successful treatment
EXPERIMENTALThe successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
7 days failed treatment
EXPERIMENTALThe failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
10 days Successful treatment
EXPERIMENTALThe successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
10 days failed treatment
EXPERIMENTALThe failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
14 days Successful treatment
EXPERIMENTALThe successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
14 days failed treatment
EXPERIMENTALThe failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.
Interventions
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
Eligibility Criteria
You may qualify if:
- Age 18\~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
- Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
- C-labelled urea breath test positive.
- Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
- Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.
You may not qualify if:
- Severe heart, liver, kidney dysfunction.
- Pregnant or lactating women.
- Complications of bleeding, perforation, pyloric obstruction, cancer.
- Within 3 months before with the drugs involved in other drugs research.
- Esophageal,gastrointestinal surgery history.
- Patients can not properly express their complaints,such as psychosis, severe neurosis.
- Taking NSIAD or alcohol abusers.
- Allergic to amoxicillin or clarithromycin tested by susceptibility testing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanmen People's Hospitallead
- Wenzhou Central Hospitalcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Taizhou Hospitalcollaborator
- Affiliated Wenling Hospital of Wenzhou Medical Universitycollaborator
- Hangzhou Medical Collegecollaborator
- Centers for Disease Control and Prevention, Chinacollaborator
- Zhiyuan Medical Inspection Institutecollaborator
Study Sites (1)
Sanmen People's hospital
Taizhou, Zhejiang, 317199, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Sanmen People's Hospital
Study Record Dates
First Submitted
August 23, 2016
First Posted
October 5, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 19, 2019
Record last verified: 2018-08