Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Eradication rate, Rescue treatment
Brief summary
From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.
Detailed description
The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.
Interventions
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.
DRUGesomeprazole+bismuth+tetra+levo
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* positive results of both rapid urease test and histology, * a positive result of urea breath test, * or a positive result of culture.
Exclusion criteria
* ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）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 | six weeks after the end of anti-H pylori therapy. | Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication |
Countries
Taiwan
Participant flow
Recruitment details
1. recruitment period: February 2015 2. Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital
Pre-assignment details
None were excluded following participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole+Amox+Levo esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d. | 52 |
| Esomeprazole+Bismuth+Tetra+Levo esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d. | 50 |
| Total | 102 |
Baseline characteristics
| Characteristic | Esomeprazole+Amox+Levo | Esomeprazole+Bismuth+Tetra+Levo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 10 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 40 Participants | 79 Participants |
| Age, Continuous | 55.08 years STANDARD_DEVIATION 13.55 | 56.38 years STANDARD_DEVIATION 12.81 | 55.72 years STANDARD_DEVIATION 13.14 |
| history of smoking | 4 participants | 4 participants | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 52 Participants | 50 Participants | 102 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 52 participants | 50 participants | 102 participants |
| Sex: Female, Male Female | 35 Participants | 25 Participants | 60 Participants |
| Sex: Female, Male Male | 17 Participants | 25 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 50 |
| other Total, other adverse events | 6 / 52 | 11 / 50 |
| serious Total, serious adverse events | 0 / 52 | 0 / 50 |
Outcome results
Primary
Number of Participants in Which H. Pylori Was Eradicated
Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication
Time frame: six weeks after the end of anti-H pylori therapy.
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole+Amox+Levo | Number of Participants in Which H. Pylori Was Eradicated | 36 participants |
| Esomeprazole+Bismuth+Tetra+Levo | Number of Participants in Which H. Pylori Was Eradicated | 49 participants |
p-value: <0.001Chi-squared