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Trial record 35 of 214 for:    TETRACYCLINE

Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT03726099
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief Summary:
The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: rabeprazole, amoxicillin, furazolidone,tetracycline Phase 4

Detailed Description:
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori: A Pilot Study
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 14d concomitant therapy
Patients will receive a 14-day concomitant therapy containing rabeprazole, amoxicillin, tetracycline and furazolidone.
Drug: rabeprazole, amoxicillin, furazolidone,tetracycline
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day concomitant therapy containing rabeprazole 10mg bid, amoxicillin 1000mg bid , furazolidone 100mg bid and tetracycline 500mg qid.




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 the 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 rate 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. Changes of dyspepsia symptoms after Helicobacter pylori eradication [ Time Frame: 6 months ]
    A list of dyspepsia symptoms will be recorded. Difference of dyspepsia symptoms before and after the therapy will be compared.

  3. The rate 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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-70 with persistent H. pylori infection.
  • Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

  • Patients unable or unwilling to receive gastroscopy.
  • Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
  • Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
  • History of allergy to any of the drugs used in the study.
  • Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
  • Currently pregnant or lactating.
  • Severe neurologic or psychiatric disorders.
  • Alcohol abuse or drug addiction.
  • Patients with compliance lower than 90% in any previous treatment are not included.
  • 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): NCT03726099


Contacts
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Contact: Xiuli Zuo, MD,PhD 8653182169025 ext 8653182169025 qlywc@163.com
Contact: Xiuli Zuo, MD,PhD 8653182169025 ext 8653182169025 qlywc@163.com

Locations
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China, Shandong
Xiuli Zuo
Jinan, Shandong, China
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: NCT03726099     History of Changes
Other Study ID Numbers: 2018SDU-QILU-G004
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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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:
Concomitant Therapy
Rescue treatment
Additional relevant MeSH terms:
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Tetracycline
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Furazolidone
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Monoamine Oxidase Inhibitors