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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| furazolidone-tetracycline-containing quadruple | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furazolidone | Drug | Furazolidone-tetracycline-containing quadruple regimens |
|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuli Zuo, MD,PhD | Contact | 15588818685 | zuoxiuli@sina.com | |
| Xiuli Zuo | Contact | 15588818685 | zuoxiuli@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zuo, MD,PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hosipital | Recruiting | Jinan | Shandong | 257000 | China |
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| ID | Term |
|---|---|
| D005664 | Furazolidone |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D023303 | Oxazolidinones |
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| Metronidazole | Drug | metronidazole-tetracycline-containing quadruple regimens |
|
| D010080 |
| Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005663 | Furans |
| D009593 | Nitroimidazoles |
| D007093 | Imidazoles |