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Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment

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ClinicalTrials.gov Identifier: NCT02988089
Recruitment Status : Unknown
Verified April 2017 by Yanqing Li, Shandong University.
Recruitment status was:  Recruiting
First Posted : December 9, 2016
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
Shandong Provincial Hospital
General Hospital of Jinan Military Region
Binzhou People's Hospital
Liaocheng People's Hospital
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Brief Summary:
Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Antimicrobial Susceptibility Testing Drug: Clarithromycin susceptibility dependant strategy Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ) Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone Drug: amoxicillin and furazolidone or amoxicillin and tetracycline Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: clarithromycin dependant group

Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.

The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin.

If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.

Drug: Clarithromycin susceptibility dependant strategy

Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin.

If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.


Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
all patients need these two drugs.

Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone
patients in the 6 antibiotics dependant group will use these intervention.

Experimental: 6 antibiotics dependant group

Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.

Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.

Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )
Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.

Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
all patients need these two drugs.

salvage therapy for negative culture
when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen),all are used twice daily except tetracycline which is taken 3 times daily.
Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
all patients need these two drugs.

Drug: amoxicillin and furazolidone or amoxicillin and tetracycline
salvage therapy for negative culture when the results of culture are negative

salvage therapy for failed eradication
If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d.
Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
all patients need these two drugs.

Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin
salvage therapy for failed eradication if failed with AST guided eradication therapy




Primary Outcome Measures :
  1. Eradication rates in 2 groups [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. the rate of improving dyspepsia symptoms after H. pylori eradication [ Time Frame: 6 months ]
  2. the rate of adverse events happening [ Time Frame: 6 months ]
  3. the rate of good compliance (take pills more than 90%) [ Time Frame: 5 months ]
  4. difference of cost per patient for each eradication achieved in 2 groups [ Time Frame: 6 months ]


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:

  • Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion Criteria:

  • Enable to undergo upper endoscopy;
  • Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
  • Known or suspected allergy to study medications;
  • Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
  • 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): NCT02988089


Contacts
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Contact: Li Yanqing, MD, PhD 86-531-82169236 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Ji'nan, Shandong, China, 250012
Contact: Yanqing Li, MD, PhD    86-531-82169236    liyanqing@sdu.edu.cn   
Contact: Yanqing Li, MD, PhD    86-0531-82169236    liyanqing@sdu.edu.cn   
Sponsors and Collaborators
Shandong University
Shandong Provincial Hospital
General Hospital of Jinan Military Region
Binzhou People's Hospital
Liaocheng People's Hospital
Investigators
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Principal Investigator: Li Yanqing, MD, PhD Qilu Hospital of Shandong University

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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02988089     History of Changes
Other Study ID Numbers: 2016SDU-QILU-23
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Yanqing Li, Shandong University:
Helicobacter Pylori Infection
Antimicrobial susceptibility testing (AST)

Additional relevant MeSH terms:
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Disease Susceptibility
Helicobacter Infections
Disease Attributes
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Tetracycline
Tinidazole
Antibiotics, Antitubercular
Furazolidone
Anti-Infective Agents
Proton Pump Inhibitors
Bismuth
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors