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Early termination due to efficacy
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levofloxacin-Amoxicillin/clavulanate | Experimental | 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. |
|
| Clarithromycin-Amoxicillin | Active Comparator | 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin-Amox/clav. | Drug | Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks after complete use of drug for treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks after complete use of drug for treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks after complete use of drug for treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Cheh CHEN, MD | Buddhist Tzu Chi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buddhist Tzu Chi General Hospital | Hualien City | Taiwan | 97002 | Taiwan |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levofloxacin-Amox/Clav. | 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. |
| FG001 | Clarithromycin-Amoxicillin | 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levofloxacin-Amox/Clav. | 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. |
| BG001 | Clarithromycin-Amoxicillin | 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of eradicated participants | 4 weeks after complete use of drug for treatment |
|
Since participants enrolled into the study till completed the follow up, at least five weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levofloxacin-Amox/Clav. | 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visited our emergency room | Gastrointestinal disorders | Non-systematic Assessment | Vomiting during eradication, visited our ER, improved after symptomatic treatment, then the case was loss in follow up. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea / Hiccough | Gastrointestinal disorders | Non-systematic Assessment | Hiccough and/or sensation of nausea |
The limitation of this study is the local primary resistance of Hp to levofloxacin and to amoxicillin/clavulanate is unknown. We are currently engaged in an on-going investigation of the influence of CYP2C19 genotypes on this new regimen.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ming-Cheh, Chen | Buddhist Tzu Chi General Hospital | +886-910-521003 | MingCheh_chen@tzuchi.com.tw |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D000074584 | WW Domain-Containing Oxidoreductase |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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|
| Clarithromycin-Amoxicillin | Drug | Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days. |
|
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Resident area | Comparison about resident area of participants, living in urban area or rural area. | Number | participants |
|
| Endoscopic finding | Comparison between participant's endoscopic finding with or without peptic ulcer disease. | Number | participants |
|
| Follow up method | Information about the follow up method to confirmed the post-treatment Hp status of participants. | Number | participants |
|
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
|
|
|
| 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. | This intent-to treat analysis is without control group, including patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin. | Posted | Number | percentage of successful re-eradication | 4 weeks after complete use of drug for treatment |
|
|
|
| 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. | Subgroup analysis (intent-to-treat) on eradication rate of participants who are living in rural area of Taiwan. | Posted | Number | percentage of eradicated participants | 4 weeks after complete use of drug for treatment |
|
|
|
|
| 1 |
| 73 |
| 10 |
| 73 |
| EG001 | Clarithromycin-Amoxicillin | 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. | 0 | 73 | 11 | 73 |
| EG002 | 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. | 0 | 62 | 17 | 62 |
|
|
| Loose stool / Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Diarrhea or loose stool passage. |
|
| Change in appetite / Bitter sensation | Gastrointestinal disorders | Non-systematic Assessment | Bitter sensation in tongue, change in taste or appetite. |
|
| Abdominal fullness / Flatus | Gastrointestinal disorders | Non-systematic Assessment | Flatus, abdominal fullness and gas passage. |
|
| Insomnia | General disorders | Non-systematic Assessment | Poor sleep. |
|
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| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |