Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin

Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Furazolidone; Drug: Tinidazole

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Qilu hospital
      • Sub-Investigator: Minjuan Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Furazolidone; Furazolidone-tetracycline-containing quadruple regimens
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.	Drug: Tinidazole; tinidazole-tetracycline-containing quadruple regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rates in 2 groups	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.	12months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: February 8, 2020
• First Submitted That Met QC Criteria: February 8, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Allergic; Penicillin; Tetracycline; Rescue Therapy; Furazolidone
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Alkylating Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Monoamine Oxidase Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Tinidazole; Furazolidone
• Other Study ID Numbers: 2019-SDU-QILU-G226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No