Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin

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: NCT04264663
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief Summary:
The purpose of this study is to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Furazolidone Drug: Tinidazole 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.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: furazolidone-tetracycline-containing quadruple
patients in furazolidone-tetracycline-containing quadruple group will receive lansoprazole 30mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and furazolidone 100mg po bid for 14d
Drug: Furazolidone
Furazolidone-tetracycline-containing quadruple regimens

Active Comparator: tinidazole-tetracycline-containing quadruple group
patients in tinidazole-tetracycline-containing quadruple group will receive lansoprazole 30mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and tinidazole 500mg po tid for 14d.
Drug: Tinidazole
tinidazole-tetracycline-containing quadruple regimens




Primary Outcome Measures :
  1. Eradication rates in 2 groups [ Time Frame: 12months ]
    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: 12months ]
    The rate of improving dyspepsia symptoms after Helicobacter pylori eradication

  2. The rate of adverse events happening [ Time Frame: 12months ]
    Similarly, adverse events will also be measured by the Likert scale.

  3. The rate of good compliance [ Time Frame: 12months ]
    The rate of good compliance



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.
  • Patients with previous Helicobacter pylori eradication.
  • Patients Allergic to Penicillin.

Exclusion Criteria:

  • 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): NCT04264663


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

Locations
Layout table for location information
China, Shandong
Qilu hospital Recruiting
Jinan, Shandong, China, 250000
Contact: Xiuli Zuo, MD,PhD    15588818685 ext 053188369277    zuoxiuli@sina.com   
Sub-Investigator: Minjuan Lin         
Sponsors and Collaborators
Shandong University
Investigators
Layout table for investigator information
Principal Investigator: Xiuli Zuo, MD,PhD 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: NCT04264663    
Other Study ID Numbers: 2019-SDU-QILU-G226
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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:
Allergic
Penicillin
Rescue Therapy
Tetracycline
Furazolidone
Additional relevant MeSH terms:
Layout table for MeSH terms
Penicillins
Tetracycline
Tinidazole
Furazolidone
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Monoamine Oxidase Inhibitors