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The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the treatment of Hard-to-treat Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.
This study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14d concomitant therapy | Experimental | Patients will receive a 14-day concomitant therapy consisting of vonoprazan and three kinds of antibiotics including amoxicillin,tetracycline, furazolidone, clarithromycin,levofloxacin,tinidazole,metronidazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| three kinds of antibiotics including amoxicillin,tetracycline, furazolidone, levofloxacin,clarithromycin,levofloxacin,tinidazole,metronidazol | Drug | Three kinds of antibiotics including amoxicillin,tetracycline, furazolidone, levofloxacin,clarithromycin,tinidazole,metronidazol |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rates | Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis. results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. of Helicobacter pylori infection. The ITT analysis includes all the 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. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of adverse events happening | At the follow-up, adverse events complained by patients will be recorded by an independent researcher.Adverse events were graded as mild, moderate, or severe. | 6 month |
| Compliance of patients |
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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, MD,PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zuo, MD,PhD | Study Principal investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hosipital | Jinan | Shandong | 257000 | China |
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|
Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.
| 6 month |
| ID | Term |
|---|---|
| D005664 | Furazolidone |
| D064704 | Levofloxacin |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005663 | Furans |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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