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With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored therapy | Experimental | After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days. |
|
| Empiric therapy | Active Comparator | give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | proton pump inhibitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by Ā¹Ā³C-urea breath test. Eradication was defined as negative result from urea breath test (<4ā°) (4ā° as the cutoff value). | Six weeks after completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse effects | During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities). The side effect score recorded was based on the most severe event. |
| Measure | Description | Time Frame |
|---|---|---|
| Medical cost per patient of tailored or empiric therapy | two months after completion of therapy | |
| Ratio of medical cost to H. pylori eradication rate of each therapy | two months after completion of therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Lu, M.D. | Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | Study Chair |
| Yunwei Sun, M.D. | Ruijin Hospital | Principal Investigator |
| Hong Gao, M.D. | Fudan University | Principal Investigator |
| Yan Zhao, M.D. | Shanghai Tenth People's Hospital, Tongji University | Principal Investigator |
| Gang Xu, M.D. | Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200001 | China | ||
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2016 | Jun 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Bismuth Potassium Citrate |
| Drug |
Gastric mucosal protective drug with anti-H. pylori effect |
|
| Amoxicillin | Drug | antibiotic for H. pylori eradication |
|
| Clarithromycin | Drug | antibiotic for H. pylori eradication |
|
| Metronidazole | Drug | antibiotic for H. pylori eradication |
|
| Levofloxacin | Drug | antibiotic for H. pylori eradication |
|
| within 7 days after completion of therapy |
| Compliance rate | Compliance was deļ¬ned as poor when they had taken less than 80% of the total medication. | within 7 days after completion of therapy |
| Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric therapy | two months after completion of therapy |
| Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University |
| Shanghai |
| Shanghai Municipality |
| 200001 |
| China |
| Shanghai Tenth People's Hospital, Tongji University | Shanghai | Shanghai Municipality | 200001 | China |
| Zhongshan Hospital,Fudan University | Shanghai | Shanghai Municipality | 200001 | China |
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200127 | China |
| 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 |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |