Helicobacter Pylori Rescue Treatment in Patients Allergic to Penicillin
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: furazolidone-tetracycline-containing quadruple 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 |
Drug: Furazolidone
Furazolidone-tetracycline-containing quadruple regimens
|
Active Comparator: metronidazole-tetracycline-containing quadruple group 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
metronidazole-tetracycline-containing quadruple regimens
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged 18-70 with H. pylori infection.
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Patients with previous Helicobacter pylori eradication.
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Patients Allergic to Penicillin.
Exclusion Criteria:
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Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
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Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
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Patients with known or suspected allergy to study medications.
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Currently pregnant or lactating.
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Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Qilu hosipital | Jinan | Shandong | China | 257000 |
Sponsors and Collaborators
- Shandong University
Investigators
- Principal Investigator: Xiuli Zuo, MD,PhD, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-SDU-QILU-G226