Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Levofloxacin, Amoxicillin/clavulanate, Rabeprazole, Eastern Taiwan
Brief summary
This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan.
Detailed description
BACKGROUND: The resistance rate of Helicobacter pylori (Hp) to amoxicillin and metronidazole therapy is significantly higher in Eastern Taiwan as compared to national and worldwide rates. The high resistance rate in this territory justified a search for a better eradication regimen for Hp infection. AIM: To evaluate the efficacy and tolerability of a combination therapeutic regimen of levofloxacin, amoxicillin/clavulanate and rabeprazole (LAcR) versus a conventional seven-day triple therapy with clarithromycin, amoxicillin and rabeprazole (CAR) for the eradication of Hp infection. METHODS: We conducted a open-labeled, prospective, randomized, controlled study in a large tertiary referral hospital in Eastern Taiwan. Hp-positive therapy-naïve patients with a positive CLO test as proven by gastroscopy were recruited for potential random assignment to two 7-day treatment groups: LAcR or CAR (control). The primary end point of this study was to evaluate the eradication rate of LAcR regimen. Hp eradication was assessed using the 13C-urea breath test or CLO test performed at least 4 weeks after end of treatment. Compliance and adverse effects with therapy were determined by phone call or outpatient clinic follow up. EXPECTED RESULT: The seven-day LAcR regimen evaluated in this study provided improved Hp eradication efficacy when compared with the traditional seven-day triple therapy in Eastern Taiwan.
Interventions
DRUGLevofloxacin-Amox/clav.
Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.
DRUGClarithromycin-Amoxicillin
Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Patient proved with infection of H. pylori in gastric mucosa * Patient with signed informed consent.
Exclusion criteria
* woman in breast feeding or pregnancy. * allergy or severe adverse effects to drugs used in study. * severe complications of peptic ulcer disease (like perforation or obstruction). * patients with history of cancer or failure of major organs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication Rate (Participants Naive to Anti-H. Pylori Treatment) | 4 weeks after complete use of drug for treatment | A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eradication Rate of Participants Living in Rural Area. | 4 weeks after complete use of drug for treatment | Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Re-eradication Rate | 4 weeks after complete use of drug for treatment | Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin. |
Countries
Taiwan
Participant flow
Recruitment details
We included H. pylori-positive adult patients assessed by the rapid urease test and histology during the period December 2007 to December 2009 from the out-patient clinic of a single medical center located at Hualien, Eastern Taiwan.
Pre-assignment details
We excluded patients under the age of 20, woman in pregnancy or breast feeding, those with concomitant illness or conditions (i.e., cardiopulmonary, hepatic, renal diseases, neoplastic diseases), those with severe complication of peptic ulcer disease, like obstruction or perforation, those with allergy to any of the drugs used.
Participants by arm
| Arm | Count |
|---|---|
| Levofloxacin-Amox/Clav. 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. | 73 |
| Clarithromycin-Amoxicillin 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. | 73 |
| Levofloxacin-Amox/Clav. (Re-eradication) 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication. | 62 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 | 2 |
| Overall Study | Protocol Violation | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) | Total |
|---|---|---|---|---|
| Age Continuous | 52.82 years STANDARD_DEVIATION 12.08 | 54.63 years STANDARD_DEVIATION 14.42 | 54.68 years STANDARD_DEVIATION 11.81 | 54.01 years STANDARD_DEVIATION 12.77 |
| Age, Customized < 54 years | 38 participants | 34 participants | 25 participants | 97 participants |
| Age, Customized >=54 years | 35 participants | 39 participants | 37 participants | 111 participants |
| Endoscopic finding Without peptic ulcer | 43 participants | 38 participants | 41 participants | 122 participants |
| Endoscopic finding With peptic ulcer | 30 participants | 35 participants | 21 participants | 86 participants |
| Follow up method C13-UBT | 65 participants | 65 participants | 55 participants | 185 participants |
| Follow up method CLO test | 5 participants | 4 participants | 5 participants | 14 participants |
| Follow up method No follow up | 3 participants | 4 participants | 2 participants | 9 participants |
| Resident area Rural area | 43 participants | 49 participants | 43 participants | 135 participants |
| Resident area Urban area | 30 participants | 24 participants | 19 participants | 73 participants |
| Sex: Female, Male Female | 35 Participants | 40 Participants | 38 Participants | 113 Participants |
| Sex: Female, Male Male | 38 Participants | 33 Participants | 24 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 73 | 11 / 73 | 17 / 62 |
| serious Total, serious adverse events | 1 / 73 | 0 / 73 | 0 / 62 |
Outcome results
Primary
Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.
Time frame: 4 weeks after complete use of drug for treatment
Population: Intent to treat analysis of eradication (negative result of follow up method) measured 4 weeks after complete the treatment, for participants never received anti-H. pylori treatment before.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levofloxacin-Amox/Clav. | Eradication Rate (Participants Naive to Anti-H. Pylori Treatment) | 78.1 percentage of eradicated participants |
| Clarithromycin-Amoxicillin | Eradication Rate (Participants Naive to Anti-H. Pylori Treatment) | 57.5 percentage of eradicated participants |
p-value: 0.00895% CI: [1.28, 5.42]Chi-squared
Secondary
Eradication Rate of Participants Living in Rural Area.
Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area.
Time frame: 4 weeks after complete use of drug for treatment
Population: Subgroup analysis (intent-to-treat) on eradication rate of participants who are living in rural area of Taiwan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levofloxacin-Amox/Clav. | Eradication Rate of Participants Living in Rural Area. | 81.4 percentage of eradicated participants |
| Clarithromycin-Amoxicillin | Eradication Rate of Participants Living in Rural Area. | 51.3 percentage of eradicated participants |
p-value: 0.00495% CI: [1.5, 10.02]Chi-squared
Other Pre-specified
Re-eradication Rate
Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
Time frame: 4 weeks after complete use of drug for treatment
Population: This intent-to treat analysis is without control group, including patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levofloxacin-Amox/Clav. | Re-eradication Rate | 72.6 percentage of successful re-eradication |