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Trial record 3 of 601 for:    Anti-Infective Agents AND susceptibility

Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT03658746
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief Summary:
The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline) Drug: one proton pump inhibitor, colloidal bismuth pectin Drug: two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone) Phase 4

Detailed Description:

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection.

The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection-A Randomized Clinical Trial
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Antimicrobial susceptibility guided therapy

Patients in this group will receive a 14-day quadruple therapy for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin, and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.

Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d, 2.Colloidal Bismuth Pectin 200mg bid for 14d, 3.two sensitive antibiotics: amoxicillin 1000mg bid for 14d, clarithromycin 500mg bid for 14d, metronidazole 500mg tid for 14d, tinidazole 500mg tid for 14d, levofloxacin 500mg qd for 14d, furazolidone 100mg bid for 14d, tetracycline 500mg qid for 14d.

Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)
Patients will receive a 14-day quadruple therapy for the H.pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.

Drug: one proton pump inhibitor, colloidal bismuth pectin
All patients need these two drugs.

Active Comparator: Empirical therapy according to medication history

Patients in this group will receive a 14-day quadruple therapy based on personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics chosen according to medication history. If the patient hasn't been treated with levofloxacin in the previous eradication regimen, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.

Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and levofloxacin 500mg qd for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.

Drug: one proton pump inhibitor, colloidal bismuth pectin
All patients need these two drugs.

Drug: two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)
Patients will receive a 14-day quadruple therapy according to personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient hasn't been treated with levofloxacin previously, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.




Primary Outcome Measures :
  1. Eradication rates [ Time Frame: 6 months ]
    Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.


Secondary Outcome Measures :
  1. The rates of adverse events happening [ Time Frame: 6 months ]
    Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.

  2. The rates of improving dyspepsia symptoms after helicobacter pylori eradication. [ Time Frame: 6 months ]
    Dyspepsia symptoms will also be measured using a 8-point Likert scale.be compared. Common adverse events will be measured using a 8-point Likert scale. Patients rate their symptoms from 0 (none) to 8 (severe) before and after the treatment process.

  3. The rates of good compliance. [ Time Frame: 6 months ]
    Patients taken over 90% of drugs are considered to have a good compliance.



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

Inclusion Criteria:

  • Patients aged 18-70 with persistent Helicobacter pylori infection.
  • Patients with previous Helicobacter pylori eradication therapy for one or two times.

Exclusion Criteria:

  • Patients unable or unwilling to receive gastroscopy.
  • Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
  • Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
  • Patients with known or suspected allergy to study medications.
  • Currently pregnant or lactating.
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

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): NCT03658746


Contacts
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Contact: Xiuli Zuo, MD,PhD 15588818685 ext 053188369277 zuoxiuli@sina.com
Contact: Xiuli Zuo, MD,PhD

Locations
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China, Shandong
Qilu hosipital
Jinan, Shandong, China, 257000
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Xiuli Zuo, MD,PhD Qilu Hospital of Shandong University

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Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
ClinicalTrials.gov Identifier: NCT03658746     History of Changes
Other Study ID Numbers: 2018SDU-QILU-G003
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiuli Zuo, Shandong University:
Antimicrobial Susceptibility Testing
Rescue Therapy

Additional relevant MeSH terms:
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Disease Susceptibility
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Antineoplastic Agents
Gastrointestinal Agents
Anti-Infective Agents, Local
Antitrichomonal Agents
Alkylating Agents
Infection
Communicable Diseases
Helicobacter Infections
Disease Attributes
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Tetracycline
Tinidazole
Antibiotics, Antitubercular
Furazolidone
Proton Pump Inhibitors