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The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of 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.
Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two 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 Option 1:Amoxicillin+Tetracycline+Furazolidone+Vonoprazan fumarate or Esomeprazole Option 2: Amoxicillin+Furazolidone+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 3: Amoxicillin+Tetracycline+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 4: Amoxicillin+Clarithromycin+Levofloxacin+Vonoprazan fumarate or Esomeprazole Three options are selected according to the actual situation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole , | Drug | Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. |
| 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#meanwhile a 8 point visual analog scale (VAS) was used to evaluate severity of adverse events. | 6 month |
| Compliance of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital | Jinan | Shandong | 250000 | China |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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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 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |