A Phase 4 interventional study of Levofloxacin-Amox/clav. and Clarithromycin-Amoxicillin in Helicobacter Pylori Infection, sponsored by Buddhist Tzu Chi General Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years to 95 Years. Per ClinicalTrials.gov, last updated 2012-08-31.
Sponsored by Buddhist Tzu Chi General Hospital · Phase 4, Interventional, and Treatment
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.
Buddhist Tzu Chi General Hospital is the lead sponsor of 84 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
Drug: Levofloxacin-Amox/clav.
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
Drug: Clarithromycin-Amoxicillin
Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.
Also known as: Levofloxacin(Cravit), Amoxicillin/clavulanate(Augmentin) and, Rabeprazole(Pariet) for 7 days.
Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.
Also known as: Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and, Rabeprazole(Pariet) for 7 days.
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
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
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
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.
| Milestone | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) |
|---|---|---|---|
| Started | 73 | 73 | 62 |
| Completed | 68 | 68 | 60 |
| Not completed | 5 | 5 | 2 |
| Withdrew: Lost to follow-up | 3 | 4 | 2 |
| Withdrew: Protocol violation | 2 | 1 | 0 |
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.
| percentage of eradicated participants | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin |
|---|---|---|
| Eradication Rate (Participants Naive to Anti-H. Pylori Treatment) | 78.1 | 57.5 |
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.
| percentage of successful re-eradication | Levofloxacin-Amox/Clav. (Re-eradication) |
|---|---|
| Re-eradication Rate | 72.6 |
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.
| percentage of eradicated participants | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin |
|---|---|---|
| Eradication Rate of Participants Living in Rural Area. | 81.4 | 51.3 |
Collected over Since participants enrolled into the study till completed the follow up, at least five weeks.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levofloxacin-Amox/Clav. | — | 1/73 (1.4%) | 10/73 (13.7%) |
| Clarithromycin-Amoxicillin | — | 0/73 (0%) | 11/73 (15.1%) |
| Levofloxacin-Amox/Clav. (Re-eradication) | — | 0/62 (0%) | 17/62 (27.4%) |
| Event | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) |
|---|---|---|---|
| Visited our emergency roomGastrointestinal disorders | 1/10 | 0/11 | 0/17 |
| Event | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) |
|---|---|---|---|
| Loose stool / DiarrheaGastrointestinal disorders | 3/73 | 1/73 | 8/62 |
| Nausea / HiccoughGastrointestinal disorders | 4/73 | 4/73 | 4/62 |
| Abdominal fullness / FlatusGastrointestinal disorders | 1/73 | 3/73 | 4/62 |
| InsomniaGeneral disorders | 1/73 | 0/73 | 4/62 |
| Change in appetite / Bitter sensationGastrointestinal disorders | 2/73 | 4/73 | 0/62 |
| Age Continuous(years) | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) | Total |
|---|---|---|---|---|
| Mean | 52.82 ± 12.08 | 54.63 ± 14.42 | 54.68 ± 11.81 | 54.01 ± 12.77 |
| Age, Customized(participants) | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) | Total |
|---|---|---|---|---|
| < 54 years | 38 | 34 | 25 | 97 |
| >=54 years | 35 | 39 | 37 | 111 |
| Sex: Female, Male(Participants) | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) | Total |
|---|---|---|---|---|
| Female | 35 | 40 | 38 | 113 |
| Male | 38 | 33 | 24 | 95 |
| Resident area(participants) | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) | Total |
|---|---|---|---|---|
| Urban area | 30 | 24 | 19 | 73 |
| Rural area | 43 | 49 | 43 | 135 |
| Endoscopic finding(participants) | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) | Total |
|---|---|---|---|---|
| With peptic ulcer | 30 | 35 | 21 | 86 |
| Without peptic ulcer | 43 | 38 | 41 | 122 |
| Follow up method(participants) | Levofloxacin-Amox/Clav. | Clarithromycin-Amoxicillin | Levofloxacin-Amox/Clav. (Re-eradication) | Total |
|---|---|---|---|---|
| C13-UBT | 65 | 65 | 55 | 185 |
| CLO test | 5 | 4 | 5 | 14 |
| No follow up | 3 | 4 | 2 | 9 |
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Buddhist Tzu Chi General Hospital