Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Furazolidone; Drug: Tinidazole

• Registration Number: NCT04264663
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-02-08
• Study First Submitted QC: 2020-02-08
• Study First Posted: 2020-02-11
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-17
• Last Update Posted: 2021-11-18
• Primary Completion: 2022-10-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
furazolidone-tetracycline-containing quadruple	Furazolidone	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
tinidazole-tetracycline-containing quadruple group	Tinidazole	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.

Primary Outcome Measures

Name	Time	Method
Eradication rates in 2 groups	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

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

Trial Locations

Locations (1)

Qilu hospital; 🇨🇳 Jinan, Shandong, China