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| Name | Class |
|---|---|
| E-DA Hospital | OTHER |
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To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy
About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levofloxacin-based sequential therapy | Experimental | levofloxacin-based sequential therapy |
|
| levofloxacin-based triple therapy | Active Comparator | levofloxacin-based triple therapy for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levofloxacin-based sequential therapy | Drug | levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕 |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate in the second line therapy | Assessed by UBT | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse effect | during treatment | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jyh-Ming Liou, MD | Contact | 886-972651883 | dtmed046@pchome.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Jyh-Ming Liou, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, Hsinchu Branch | Recruiting | Hsinchu | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21632579 | Background | Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31. | |
| 26832653 |
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|
| levofloxacin-based triple therapy for 10 days | Drug | lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily) |
|
|
| E-DA Hospital and I-Shou University | Recruiting | Kaohsiung City | Taiwan |
|
| Kaohsiung Medical University | Recruiting | Kaohsiung City | Taiwan |
|
| Health Bureau of Lienchiang County | Recruiting | Lienchiang | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
|
| Mackay Memorial Hospital | Recruiting | Taipei | Taiwan |
|
| Taipei Medical University Hospital | Recruiting | Taipei | Taiwan |
|
| Taipei Veteran General Hospital | Recruiting | Taipei | Taiwan |
|
| Mackay Memorial Hospital | Recruiting | Taitung Branch | Taiwan |
|
| National Taiwan University Hospital , Yunlin | Recruiting | Yunlin | Taiwan |
|
| Liou JM, Bair MJ, Chen CC, Lee YC, Chen MJ, Chen CC, Tseng CH, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Chang WH, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hung HW, Lin JT, Chang CY, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Levofloxacin Sequential Therapy vs Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori: A Randomized Trial. Am J Gastroenterol. 2016 Mar;111(3):381-7. doi: 10.1038/ajg.2015.439. Epub 2016 Feb 2. |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D008795 | Metronidazole |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
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