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This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.
This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the treatment of Helicobacter pylori in patients with chronic gastritis. This study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. At the same time, it will provide reference for the reasonable pricing of H.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotypic resistance guided therapy | Experimental | After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days. |
|
| Phenotypic resistance guided therapy | Experimental | After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days. |
|
| Empiric therapy | Active Comparator | Esomeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g bid (no penicillin allergy) OR tetracycline 0.5g qid (penicillin allergy) for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of Helicobacter pylori | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of Helicobacter pylori resistant strains | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method. | 6 weeks |
| Eradication rate of Helicobacter pylori susceptible strains |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate | The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication. | 2 weeks during therapy |
| Frequency of adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Chen, MD | Contact | 86-17811921405 | chenqimd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Gao, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Hong Gao at gao.hong@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
Beginning 6 months and ending 5 years after the trial results were published.
All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D008795 | Metronidazole |
| D017291 | Clarithromycin |
| D064704 | Levofloxacin |
| D000658 | Amoxicillin |
| D013752 | Tetracycline |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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The technicians, who performed culture, antimicrobial susceptibility testing or urea breath test were blinded to treatment allocation.
| Bismuth potassium citrate | Drug | 0.6g bid |
|
| Metronidazole | Drug | 0.4g qid |
|
| Clarithromycin | Drug | 0.5g bid |
|
| Levofloxacin | Drug | 0.5g qd |
|
| Amoxicillin | Drug | 1g bid |
|
| Tetracycline | Drug | 0.5g qid |
|
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method. |
| 6 weeks |
Any possible adverse events during the 14-day treatment period were recorded.
| 2 weeks during therapy |
| Average cost of each group | Average medical cost related to therapy and followup in each group | 6 weeks |
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Huashan Hospital, Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200040 | 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 |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |