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Trial record 28 of 389 for:    CLARITHROMYCIN

A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Using Clarithromycin

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ClinicalTrials.gov Identifier: NCT02923856
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : February 19, 2019
Sponsor:
Collaborators:
Wenzhou Central Hospital
The First Affiliated Hospital with Nanjing Medical University
Taizhou Central Hospital
The first people Hospital of Wenling
The first people Hospital of Yongkang
Centers for Disease Control and Prevention, China
Zhiyuan Medical Inspection Institute
Information provided by (Responsible Party):
Hongzhang Li, Sanmen People's Hospital

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.

Condition or disease Intervention/treatment Phase
Gastritis Device: The results of clarithromycin susceptibility test of H. pylori isolates Device: Computer generated random number, randomly assigned into groups Device: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Based on Accurate Susceptibility Testing of Clarithromycin
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clarithromycin resistance group
Patients who are resistant to clarithromycin in susceptibility test were classified into clarithromycin resistance group.
Device: The results of clarithromycin susceptibility test of H. pylori isolates
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.

Experimental: 7 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
Device: The results of clarithromycin susceptibility test of H. pylori isolates
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.

Device: Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.

Device: The result of 13C-urea breath test of patient in 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.

Experimental: 7 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
Device: The results of clarithromycin susceptibility test of H. pylori isolates
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.

Device: Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.

Device: The result of 13C-urea breath test of patient in 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.

Experimental: 10 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
Device: The results of clarithromycin susceptibility test of H. pylori isolates
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.

Device: Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.

Device: The result of 13C-urea breath test of patient in 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.

Experimental: 10 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
Device: The results of clarithromycin susceptibility test of H. pylori isolates
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.

Device: Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.

Device: The result of 13C-urea breath test of patient in 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.

Experimental: 14 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
Device: The results of clarithromycin susceptibility test of H. pylori isolates
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.

Device: Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.

Device: The result of 13C-urea breath test of patient in 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.

Experimental: 14 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.
Device: The results of clarithromycin susceptibility test of H. pylori isolates
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.

Device: Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.

Device: The result of 13C-urea breath test of patient in 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.




Primary Outcome Measures :
  1. The accurate determination of clarithromycin susceptibility. [ Time Frame: 2 years ]
    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. Establish individualized precision triple therapy based on minimal inhibitory concentration. [ Time Frame: 2.5 years ]
    Based on the clarithromycin accurate susceptibility,pinpoint different courses of triple treatment therapy targeted to different people based on minimal inhibitory concentration of clarithromycin.


Secondary Outcome Measures :
  1. The incidence of adverse effects [ Time Frame: 3 years ]
    Drugs targeted, it could reduce the intake of antibiotics for patients.The incidence of adverse effects in the eradicate treatment will reduce. Avoid patients' unnecessary economic losses.


Other Outcome Measures:
  1. Impact of mixed infection and CYP2C19 genotype on eradication rate for Helicobacter pylori with triple therapy using clarithromycin. [ Time Frame: 3 years ]
    Investigators will perform a sequencing for failed treatment patients in groups, such as drug resistance gene mutation,and CYP2C19 genotype. Evaluating the impact of mixed infection and CYP2C19 genotype on eradication rate for Helicobacter pylori with triple therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
  2. Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
  3. Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
  4. 13C-labelled urea breath test positive.
  5. Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
  6. Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.

Exclusion Criteria:

  1. Severe heart, liver, kidney dysfunction.
  2. Pregnant or lactating women.
  3. Complications of bleeding, perforation, pyloric obstruction, cancer.
  4. Within 3 months before with the drugs involved in other drugs research.
  5. Esophageal,gastrointestinal surgery history.
  6. Patients can not properly express their complaints,such as psychosis, severe neurosis.
  7. Taking NSIAD or alcohol abusers.
  8. Allergic to amoxicillin or clarithromycin tested by susceptibility testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923856


Contacts
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Contact: zhang hong Li, doctor smyylhz@163.com

Locations
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China, Zhejiang
Sanmen People's hospital Recruiting
Taizhou, Zhejiang, China, 317199
Contact: zhang hong Li, doctor       smyylhz@163.com   
Sponsors and Collaborators
Sanmen People's Hospital
Wenzhou Central Hospital
The First Affiliated Hospital with Nanjing Medical University
Taizhou Central Hospital
The first people Hospital of Wenling
The first people Hospital of Yongkang
Centers for Disease Control and Prevention, China
Zhiyuan Medical Inspection Institute

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Responsible Party: Hongzhang Li, Director of Sanmen People's Hospital, Sanmen People's Hospital
ClinicalTrials.gov Identifier: NCT02923856     History of Changes
Other Study ID Numbers: SanmenPH
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: August 2018
Keywords provided by Hongzhang Li, Sanmen People's Hospital:
Helicobacter pylori
Antibiotic resistance
Sequencing
Additional relevant MeSH terms:
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Clarithromycin
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors