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Trial record 94 of 214 for:    TETRACYCLINE

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03139253
Recruitment Status : Unknown
Verified May 2017 by Yanqing Li, Shandong University.
Recruitment status was:  Not yet recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
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
Antimicrobial Susceptibility Testing Triple Therapy Drug: amoxicillin Drug: clarithromycin Drug: tinidazole Drug: levofloxacin Drug: furazolidone Drug: tetracycline Drug: Ilaprazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment
Estimated Study Start Date : May 30, 2017
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: clarithromycin susceptible

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin.

Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).

Drug: amoxicillin
amoxicillin 1000 mg bid. for 14 days

Drug: clarithromycin
clarithromycin 500 mg bid. for 14 days.

Drug: Ilaprazole
Ilaprazole 5 mg bid. for 14 days.

Experimental: metronidazole susceptible
Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.
Drug: amoxicillin
amoxicillin 1000 mg bid. for 14 days

Drug: tinidazole
tinidazole 500 mg bid. for 14 days.

Drug: Ilaprazole
Ilaprazole 5 mg bid. for 14 days.

Experimental: levofloxacin susceptible
Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.
Drug: amoxicillin
amoxicillin 1000 mg bid. for 14 days

Drug: levofloxacin
levofloxacin 500 mg qd. for 14 days.

Drug: Ilaprazole
Ilaprazole 5 mg bid. for 14 days.

Experimental: furazolidone susceptible
Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.
Drug: amoxicillin
amoxicillin 1000 mg bid. for 14 days

Drug: furazolidone
furazolidone 100 mg bid. for 14 days.

Drug: Ilaprazole
Ilaprazole 5 mg bid. for 14 days.

Experimental: tetracycline susceptible
Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.
Drug: amoxicillin
amoxicillin 1000 mg bid. for 14 days

Drug: tetracycline
tetracycline 750 mg bid. for 14 days.

Drug: Ilaprazole
Ilaprazole 5 mg bid. for 14 days.




Primary Outcome Measures :
  1. Eradication rate of AST guided triple therapy [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. the rate of improving dyspepsia symptoms after H. pylori eradication [ Time Frame: 3 months ]
  2. the rate of adverse events happening [ Time Frame: 3 months ]
  3. the rate of good compliance (take pills more than 90%) [ Time Frame: 3 months ]


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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): NCT03139253


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

Sponsors and Collaborators
Yanqing Li
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: NCT03139253     History of Changes
Other Study ID Numbers: 2017SDU-QILU-02
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 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)
Triple Therapy
Additional relevant MeSH terms:
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Tetracycline
Disease Susceptibility
Disease Attributes
Pathologic Processes
Amoxicillin
Clarithromycin
Anti-Bacterial Agents
Levofloxacin
Ofloxacin
Tinidazole
Furazolidone
Anti-Infective 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
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Alkylating Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Local
Monoamine Oxidase Inhibitors