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This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL group | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days |
|
| LM group | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days |
|
| CM group | Active Comparator | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole | 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). | At least 4 weeks after completion of therapy |
| 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. | At least 4 weeks after completion of therapy |
| Eradication rate of Helicobacter pylori susceptible strains |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate | Adherence was defined as poor when subjects took less than 80% of the total medication. | 2 weeks during therapy |
| Frequency of adverse events | Any possible adverse events during the 14-day treatment period were recorded. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Chen, MD | Contact | 86-17811921405 | chenqimd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Taotao Liu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | 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 Taotao Liu at liu.taotao@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 |
|---|---|
| D064750 | Rabeprazole |
| D008795 | Metronidazole |
| D017291 | Clarithromycin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Bismuth potassium citrate |
| Drug |
0.6g bid |
|
| Metronidazole | Drug | 0.4g qid |
|
| Clarithromycin | Drug | 0.5g bid |
|
| Levofloxacin | Drug | 0.5g qd |
|
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. |
| At least 4 weeks after completion of therapy |
| 2 weeks during therapy |
| 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 |