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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Levofloxacin
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levofloxacin-tetracycline-containing quadruple group<br>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 | Drug: Levofloxacin<br>* levofloxacin-tetracycline-containing quadruple regimens<br>|
| Active Comparator: metronidazole-tetracycline-containing quadruple group<br>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 | Drug: Metronidazole<br>* Metronidazole-tetracycline-containing quadruple regimens<br>|

What is the study measuring?
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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. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Eradication, Allergic, Penicillin, Tetracycline