Helicobacter Pylori Rescue Treatment in Patients Allergic to Penicillin

Phase 4

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

• Registration Number: NCT05135182
• Lead Sponsor: Shandong University

Brief Summary

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

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-11-26
• Study Start: 2021-11-28
• Last Update Submitted: 2021-11-28
• Last Update Posted: 2021-11-30
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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 vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid , bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone 100mg po bid for 14d
metronidazole-tetracycline-containing quadruple group	Metronidazole	patients in metronidazole-tetracycline-containing quadruple group will receive vonoprazan fumarate 20mg po bid,tetracycline 500mg po qid , bismuth potassium citrate(Lizhudele) 220mg po bid, and metronidazole 400mg po qid for 14d.

Primary Outcome Measures

Name	Time	Method
Eradication rates in 2 groups	12 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.

Trial Locations

Locations (1)

Qilu hosipital; 🇨🇳 Jinan, Shandong, China