Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin

Overview

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.

Full Title of Study: “Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 30, 2022

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.

Interventions

  • Drug: Furazolidone
    • Furazolidone-tetracycline-containing quadruple regimens
  • Drug: Tinidazole
    • tinidazole-tetracycline-containing quadruple regimens

Arms, Groups and Cohorts

  • Experimental: furazolidone-tetracycline-containing quadruple
    • patients in furazolidone-tetracycline-containing quadruple group will receive Esomeprazole 40mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and furazolidone 100mg po bid for 14d
  • Active Comparator: tinidazole-tetracycline-containing quadruple group
    • patients in tinidazole-tetracycline-containing quadruple group will receive Esomeprazole 40mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and tinidazole 500mg po tid for 14d.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
    • Time Frame: 12months
    • The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
  • The rate of adverse events happening
    • Time Frame: 12months
    • Similarly, adverse events will also be measured by the Likert scale.
  • The rate of good compliance
    • Time Frame: 12months
    • The rate of good compliance

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiuli Zuo, director of Qilu Hospital gastroenterology department – Shandong University
  • Overall Official(s)
    • Xiuli Zuo, MD,PhD, Principal Investigator, Qilu Hospital of Shandong University
  • Overall Contact(s)
    • Xiuli Zuo, MD,PhD, 15588818685, zuoxiuli@sina.com

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