Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.
As increasing antimicrobial resistance in Korea, the effectiveness of empirical Helicobacter pylori (H. pylori) therapies have been declined. Recently, 10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication.
Thus, in this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days tailored therapy (7 day PPI based triple therapy, bismuth quadruple therapy or moxifloxacin contained triple therapy) for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 day sequential therapy for the first eradication of H. pylori infection, and the investigators analyzed the prevalence of the antibiotic resistance in the tailored therapy group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 day sequential group | Active Comparator | After proving H. pylori infection, the participant will receive the empirical 10 day sequential regimen (Esomeprazole, nexium® 40 mg bid 10 days (D1-D10)+amoxicillin® 1 g bid 5 days (D1-D5)+clarithromycin, klaricid® 500mg bid 5 days (D6-D10)+metronidazole, flasinyl® 500mg tid 5 days (D6-D10) for treatment of H. pylori infection in this group. |
|
| 7 days tailored PPI triple therapy group | Experimental | After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day tailored regimen [PPI triple therapy (Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+amoxicillin® 1 g bid 7 days (D1-D7)+clarithromycin, klaricid® 500mg bid 7 days (D1-D7)] in this group. |
|
| 7 days tailored MEA therapy group | Experimental | After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day moxifloxacin triple therapy [Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+Moxifloxacin, avelox® 400 mg qd 7 days (D1-D7)+Amoxicillin® 1 g bid 7 days (D1-D7)] in this group. |
|
| 7 or 14 days tailored EBMT therapy group | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole) | Drug | In this group, patients will receive the 10 day sequential regimen for eradication of H. pylori. 10 day sequential regimen is like follows; Esomeprazole 40 mg bid 10 days (D1-D10)+amoxicillin 1 g bid 5 days (D1-D5)+clarithromycin 500 mg bid 5 days (D6-D10)+metronidazole 500 mg tid 5 days (D6-D10). |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the percentage of participants with successful H. pylori eradication in each groups | The efficacy of H. pylori eradication between a 7 days tailored therapy for H. pylori infection based on the results of antimicrobial resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 days therapy as first eradication regimen. | 6 weeks after completion of eradication |
Not provided
Not provided
Inclusion Criteria:
The patients who proved H. pylori infection following three methods
Male and female Korean Adult (Aged ≥ 18 years)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nayoung Kim, M.D., Ph. D | Contact | 82-31-787-7008 | nayoungkim49@empas.com |
| Name | Affiliation | Role |
|---|---|---|
| Nayoung Kim, M.D., Ph. D | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
Not provided
Patients selected study
Not provided
Not provided
Not provided
Not provided
After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day bismuth quadruple therapy [Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, denol® 300 mg qid 7 days (D1-D7)+Metronidazole, flasinyl® 500 mg tid 7 days (D1-D7)+Tetracycline® 500 mg qid 7 days (D1-D7)] in this group. If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days. |
|
|
| 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy) | Drug | the participants received PPI based triple therapy[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)] |
|
|
| 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin] | Drug | moxifloxacin triple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)]. |
|
|
| 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy) | Drug | bismuth quadruple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+amoxicillin 1 g bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)], bismuth quadruple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, 300 mg qid 7 days (D1-D7)+Metronidazole, 500 mg tid 7 days (D1-D7)+Tetracycline 500 mg qid 7 days (D1-D7)] If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days. |
|
|
| ID | Term |
|---|---|
| D016481 | Helicobacter Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| 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 |
| 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 |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided