Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 605 for:    Anti-Infective Agents AND susceptibility

Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03571230
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief Summary:
The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line 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 Antimicrobial Susceptibility Testing Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline) Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone) Drug: one proton pump inhibitor(PPI) 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 pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies. 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 first-line treatment.

Our study aims to assess the efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line 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 10-day antimicrobial susceptibility test guided triple therapy has less intestinal dysbacteriosis with a shorter duration.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 10-Day Antimicrobial Susceptibility Testing Guided Triple Therapy Versus 14-Day Empirical Tailored Therapy for the First-line Treatment of Helicobacter Pylori Infection-A Randomized Controlled Trail
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 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 10-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 10d 2.two sensitive antibiotics: amoxicillin 1000mg bid for 10d, clarithromycin 500mg bid for 10d, metronidazole 500mg tid for 10d, tinidazole 500mg tid for 10d, levofloxacin 500mg qd for 10d, furazolidone 100mg bid for 10d, tetracycline 750mg bid for 10d.

Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)
Patients will receive a 10-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: 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: 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.

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: 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: 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.

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 200mg bid for 14d 3.two antibiotics for rescue therapy: tetracycline 750mg bid 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.

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

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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Exclusion Criteria:

  • Patients with previous H. pylori eradication therapy;
  • 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): NCT03571230


Contacts
Layout table for location contacts
Contact: Xiuli Zuo, PhD,MD 15588818685 ext 053188369277 zuoxiuli@sina.com

Locations
Layout table for location information
China, Shandong
Xiuli Zuo Not yet recruiting
Jinan, Shandong, China
Contact: Xiuli Zuo, PhD,MD    15588818685 ext 053188369277    zuoxiuli@sina.com   
Sub-Investigator: Jing Liu, MD         
Sub-Investigator: Chaoran Ji, MD         
Sponsors and Collaborators
Shandong University
Investigators
Layout table for investigator information
Principal Investigator: Xiuli Zuo, PhD,MD Qilu Hospital of Shandong University

Layout table for additonal information
Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
ClinicalTrials.gov Identifier: NCT03571230     History of Changes
Other Study ID Numbers: 2017SDU-QILU-G003
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Layout table for additional information
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:
Helicobacter Pylori Infection
Antimicrobial Susceptibility testing(AST)

Additional relevant MeSH terms:
Layout table for MeSH terms
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
Helicobacter Infections
Disease Attributes
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Tetracycline
Tinidazole
Antibiotics, Antitubercular
Furazolidone
Bismuth
Proton Pump Inhibitors