Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori infection
Brief summary
Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.
Detailed description
The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%. A total of 240 subjects will be asked to participate in this study. H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days). Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared. A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.
Interventions
DRUG14-day sequential treatment
* 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days * 14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
DRUG14-day hybrid treatment
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Sponsors
Baylor College of Medicine
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion criteria
* previous H. pylori-eradication therapy * ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks * patients with allergic history to the medications used * patients with previous gastric surgery * the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Which H. Pylori Was Eradicated | Dec 2010 | evaluate eradication outcome by endoscopy with urease test or urea breath test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Dec 2010 | by standardized questionnaire |
| Compliance Rate | Dec 2010 | Good compliance is defined as taking equal or more than 90% of eradication medicines |
Countries
Taiwan
Participant flow
Recruitment details
recruitment period: Aug 2008 - May 2010
Pre-assignment details
no significant events for the overall study
Participants by arm
| Arm | Count |
|---|---|
| 14-day Sequential Treatment One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. | 123 |
| 14-day Hybrid Treatment esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days | 117 |
| Total | 240 |
Baseline characteristics
| Characteristic | 14-day Hybrid Treatment | 14-day Sequential Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 26 Participants | 52 Participants |
| Age, Categorical Between 18 and 65 years | 91 Participants | 97 Participants | 188 Participants |
| Age, Continuous | 54.3 years STANDARD_DEVIATION 11.4 | 55.1 years STANDARD_DEVIATION 11.8 | 54.7 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Taiwan | 117 participants | 123 participants | 240 participants |
| Sex: Female, Male Female | 58 Participants | 62 Participants | 120 Participants |
| Sex: Female, Male Male | 59 Participants | 61 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 123 | 17 / 117 |
| serious Total, serious adverse events | 0 / 123 | 0 / 117 |
Outcome results
Primary
Number of Participants in Which H. Pylori Was Eradicated
evaluate eradication outcome by endoscopy with urease test or urea breath test
Time frame: Dec 2010
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 14-day Sequential Treatment | Number of Participants in Which H. Pylori Was Eradicated | 94 participants |
| 14-day Hybrid Treatment | Number of Participants in Which H. Pylori Was Eradicated | 99 participants |
Secondary
Adverse Events
by standardized questionnaire
Time frame: Dec 2010
Secondary
Compliance Rate
Good compliance is defined as taking equal or more than 90% of eradication medicines
Time frame: Dec 2010