Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin

Phase 4

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

• Registration Number: NCT05129176
• Lead Sponsor: Shandong University

Brief Summary

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

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-22
• Study Start: 2021-11-23
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24
• Primary Completion: 2022-07
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Patients aged 18-70 with H. pylori infection.
• Patients Allergic to Penicillin.

Exclusion Criteria

• Patients with previous H. pylori eradication therapy.
• Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
• Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
• Patients with known or suspected allergy to study medications.
• Currently pregnant or lactating.
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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
levofloxacin-tetracycline-containing quadruple group	Levofloxacin	patients in levofloxacin-tetracycline-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid , bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd 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. 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	12 months	Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.
The rate of adverse events happening	12 months	Similarly, adverse events will also be measured by the Likert scale.

Trial Locations

Locations (1)

Qilu hospital; 🇨🇳 Jinan, Shandong, China