CANHelp Working Group Treatment Trials
Study Details
Study Description
Brief Summary
The CANHelp Working Group Treatment Trials are part of a comprehensive research program carried out by the Canadian North Helicobacter pylori (CANHelp) Working Group. The treatment component involves a series of community-specific trials designed with community input and varying on the specific treatment regimens and number of treatment arms among other study details.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The CANHelp Working Group is a collaborative team that links University of Alberta researchers with Canadian northern community leaders and health officials in a collaborative effort to investigate H. pylori infection with the goal of finding solutions to community concerns about health risks. The research program uses a community-driven research approach in northern communities to characterize the burden of disease from H. pylori infection and exchange knowledge with community members and decision makers to identify ways to reduce health risks from this infection.
For the participating communities, the treatment trials aim to:
-
Estimate the effectiveness of alternate H. pylori treatment regimens to identify optimal regimens for the local setting
-
Identify factors external to the treatment regimen that influence short- and long-term treatment success
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard Triple, treatment naive Standard Triple Therapy for H. pylori: Oral twice-daily doses of rabeprazole (20 mg), amoxicillin (1 g) and clarithromycin (500 mg) One of two treatments randomly assigned to treatment naive participants in Aklavik |
Drug: Standard Triple
Oral twice-daily doses of rabeprazole (20 mg), amoxicillin (1 g) and clarithromycin (500 mg)
Other Names:
|
| Active Comparator: Sequential, treatment naive Sequential Therapy for H. pylori: Oral twice-daily doses of rabeprazole (20 mg) and amoxicillin (1 g) on days 1-5, and on days 6-10, rabeprazole (20 mg), metronidazole (500 mg) and clarithromycin (500 mg) One of two treatments randomly assigned to treatment naive participants in Aklavik, Old Crow, Tuktoyaktuk & Fort McPherson |
Drug: Sequential
Oral twice-daily doses of rabeprazole (20 mg) and amoxicillin (1 g) on days 1-5, and on days 6-10, rabeprazole (20 mg), metronidazole (500 mg) and clarithromycin (500 mg)
Other Names:
|
| Active Comparator: Quadruple, treatment naive Quadruple Thearpy for H. pylori: Oral doses of rabeprazole (20 mg) twice daily, metronidazole (500 mg) three times daily, bismuth subsalicylate (Pepto-Bismol) (2 tablets) four times daily and tetracycline (500 mg) four times daily One of two treatments randomly assigned to treatment naive participants in Old Crow, Tuktoyaktuk & Fort McPherson |
Drug: Quadruple
Oral doses of rabeprazole (20 mg) twice daily, metronidazole (500 mg) three times daily, bismuth subsalicylate (Pepto-Bismol) (2 tablets) four times daily and tetracycline (500 mg) four times daily
Other Names:
|
| Active Comparator: Sequential, previous failure(s) Sequential Therapy for H. pylori: Oral twice-daily doses of rabeprazole (20 mg) and amoxicillin (1 g) on days 1-5, and on days 6-10, rabeprazole (20 mg), metronidazole (500 mg) and clarithromycin (500 mg) One of two treatments randomly assigned to participants who previously failed one or more treatments in Aklavik, Old Crow, Tuktoyaktuk & Fort McPherson |
Drug: Sequential
Oral twice-daily doses of rabeprazole (20 mg) and amoxicillin (1 g) on days 1-5, and on days 6-10, rabeprazole (20 mg), metronidazole (500 mg) and clarithromycin (500 mg)
Other Names:
|
| Active Comparator: Quadruple, previous failure(s) Quadruple Therapy for H. pylori: Oral doses of rabeprazole (20 mg) twice daily, metronidazole (500 mg) three times daily, bismuth subsalicylate (Pepto-Bismol) (2 tablets) four times daily and tetracycline (500 mg) four times daily One of two treatments randomly assigned to participants who previously failed treatment in Aklavik, Old Crow, Tuktoyaktuk & Fort McPherson |
Drug: Quadruple
Oral doses of rabeprazole (20 mg) twice daily, metronidazole (500 mg) three times daily, bismuth subsalicylate (Pepto-Bismol) (2 tablets) four times daily and tetracycline (500 mg) four times daily
Other Names:
|
| Active Comparator: Sequential, clarithromycin-resistant Sequential Therapy for H. pylori: Oral twice-daily doses of rabeprazole (20 mg) and amoxicillin (1 g) on days 1-5, and on days 6-10, rabeprazole (20 mg), metronidazole (500 mg) and clarithromycin (500 mg) One of two treatments randomly assigned to participants with known clarithromycin resistance in Aklavik |
Drug: Sequential
Oral twice-daily doses of rabeprazole (20 mg) and amoxicillin (1 g) on days 1-5, and on days 6-10, rabeprazole (20 mg), metronidazole (500 mg) and clarithromycin (500 mg)
Other Names:
|
| Active Comparator: Quadruple, clarithromycin-resistant Quadruple Therapy for H. pylori: Oral doses of rabeprazole (20 mg) twice daily, metronidazole (500 mg) three times daily, bismuth subsalicylate (Pepto-Bismol) (2 tablets) four times daily and tetracycline (500 mg) four times daily One of two treatments randomly assigned to participants with known clarithromycin resistance in Aklavik |
Drug: Quadruple
Oral doses of rabeprazole (20 mg) twice daily, metronidazole (500 mg) three times daily, bismuth subsalicylate (Pepto-Bismol) (2 tablets) four times daily and tetracycline (500 mg) four times daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Post-treatment H. pylori status by urea breath test [A minimum of 10 weeks after participant has completed treatment]
Treatment effectiveness, defined as the probability (average risk) of elimination of H. pylori infection following treatment, measured as the proportion of trial participants with a negative post-treatment urea breath test at least 10 weeks following completion of treatment. Using an intention-to-treat analysis, the denominator for this proportion is the number of trial participants assigned treatment. Using a per-protocol analysis, the denominator for this proportion is the number of trial participants who completed treatment and were tested post-treatment. Participants are administered a urea breath test using 13C-labeled urea dissolved in a citric acid solution. We use the following test value classifications for determining the outcome: >=4.0 (Positive for H. pylori infection) Between 2.5 and 4.0 (Borderline; repeat test) Between 2.4 and -1.99 (Negative for H. pylori infection) Less than -2.0 (Uncertain test result, repeat test)
Secondary Outcome Measures
- Adherence to treatment regimen [An expected average of 1 week after treatment is completed]
Participants are asked to return blister packs with unused medication so skipped doses can be counted. Participants are also interviewed to obtain details about their adherence to the regimen.
Other Outcome Measures
- Frequency of adverse effects [From the time treatment is started to an expected average of 1 week after treatment is completed]
Participants are contacted by telephone during the completion of the treatment regimen and asked if they have experienced adverse effects. Participants are also interviewed immediately after the completion of treatment and asked if they experienced adverse effects during the completion of treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Over 15 years of age
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Identified as H. pylori infected with a positive urea breath test and/or biopsy-based evidence of H. pylori infection
Exclusion Criteria:
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Allergy to amoxicillin, metronidazole or clarithromycin
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Antibiotic therapy within 4 weeks prior to randomization
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Pregnant or breastfeeding
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Severe cardio-respiratory, pulmonary, endocrine, hepatic or renal disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alberta | Edmonton | Alberta | Canada | T6G 2E1 |
Sponsors and Collaborators
- University of Alberta
- Alberta Innovates Health Solutions
- ArcticNet
- Canadian Institutes of Health Research (CIHR)
Investigators
- Principal Investigator: Karen Goodman, PhD, University of Alberta
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Pro00007868