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Trial record 77 of 214 for:    TETRACYCLINE

Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the Rescue Treatment of Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT03565484
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 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 triple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.

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(PPI) Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone) Drug: Colloidal Bismuth Pectin Drug: two antibiotics for failed eradication(tetracyclin,furazolidone) Phase 4

Detailed Description:

Helicobacter pylori (H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathology, especially non-cardiac 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 Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the rescue treatment.

Our study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided triple therapy for the rescue treatment of Helicobacter pylori infection. Comparing this regimen with 14-day Empirical Tailored Therapy to tell which one is better in clinic practice. We also want to find whether the 14-day antimicrobial susceptibility test guided triple therapy has less adverse effects with fewer drugs.


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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: 14-Day Antimicrobial Susceptibility Testing Guided Triple Therapy Versus 14-Day Empirical Tailored Therapy as a Rescue Treatment of Helicobacter Pylori Infection—A Randomized Controlled Trail
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 30, 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 testing guided therapy

Patients in this group will receive a 14-day triple therapy for the Helicobacter pylori eradication. The regimen contains one proton pump inhibitor and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.

Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.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 750mg bid for 14d.

Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)
Patients will receive a 14-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.

Drug: one proton pump inhibitor(PPI)
All the patients need this drug.

Experimental: Empirical tailored therapy

Patients in this group will receive a 14-day bismuth based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.

Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.

Drug: one proton pump inhibitor(PPI)
All the patients need this drug.

Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)
Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.

Drug: Colloidal Bismuth Pectin
All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

Salvage therapy for negative culture

When the culture results are negative, patients will receive 14-day empirical tailored therapy based on personal medication history.

Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.

Drug: one proton pump inhibitor(PPI)
All the patients need this drug.

Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)
Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.

Drug: Colloidal Bismuth Pectin
All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

Salvage therapy for failed eradication

If patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy.

Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 220mg bid for 14d 3.two antibiotics for second rescue therapy: tetracycline 500mg qid and furazolidone 100mg bid for 14d

Drug: one proton pump inhibitor(PPI)
All the patients need this drug.

Drug: Colloidal Bismuth Pectin
All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

Drug: two antibiotics for failed eradication(tetracyclin,furazolidone)
If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.




Primary Outcome Measures :
  1. Eradication rates in 2 groups [ 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 infections in two groups. 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 rate of improving dyspepsia symptoms after Helicobacter pylori eradication. [ Time Frame: 6 months ]
    Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.


Other Outcome Measures:
  1. The rate of adverse events happening [ Time Frame: 6 months ]
    Similarly, adverse events will also be measured by the Likert scale.

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

  3. Difference of cost per patient for each eradication achieved in two groups [ Time Frame: 6 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:

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

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 gastrectomy, acute GI 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): NCT03565484


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 Not yet recruiting
Jinan, Shandong, China, 257000
Contact: Xiuli Zuo, MD,PhD    15588818685 ext 053188369277    zuoxiuli@sina.com   
Sub-Investigator: Chaoran Ji, MD         
Sub-Investigator: Jing Liu, MD         
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: NCT03565484     History of Changes
Other Study ID Numbers: 2017SDU-QILU-G004
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 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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Tetracycline
Infection
Communicable Diseases
Helicobacter Infections
Disease Susceptibility
Disease Attributes
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Tinidazole
Antibiotics, Antitubercular
Furazolidone
Bismuth
Anti-Infective Agents
Proton Pump Inhibitors
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