Comparison of Efficacy of Triple Regimen Based on Clarithromycin VS Metronidazole in Children
NCT ID: NCT04721704
Last Updated: 2021-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2020-09-14
2022-09-14
Brief Summary
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Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI) Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI The history will include presenting symptoms along duration, remission of symptoms after therapy and clinical outcome will also be recorded.
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Detailed Description
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If the strain is resistant to one of the antibiotics used, treatment success will be compromised5. As a result therapies that are recommended should be based on antibiotic susceptibility testing. If this testing is not available, then clarithromycin-based triple therapy should not be used as part of first-line therapy due to high rates of clarithromycin resistance rates6 The European Society for Paeditric Gastroenterology Hepatology and Nutrition/North American Society for Pediatric Gastroenterology, Hepatology and Nutrition made the recommendations in 2017 for the Management of Helicobacter pylori in Children that antimicrobial sensitivity should be obtained for the infecting H pylori to tailor eradication therapy accordingly and the effectiveness of first-line therapy should be evaluated in national/regional centers7.
If the strain is susceptible to clarithromycin (CLA) and to metronidazole (MET), triple therapy (PPI, amoxicillin \[AMO\], CLA) for 14 days and doses of proton pump inhibitor and antibiotics should be calculated based on the bodyweight8.
We aim to study efficacy and safety of clarithromycin vs metronidazole based triple regimen for the eradication of H pylori in children with peptic ulcer disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
Group A will be given Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI based triple regimen
Clarithromycin+ Amoxicillin + Omeprazole
In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children
Group B
Group B will be given Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI based triple regimen
Metronidazole +Amoxicillin + Omeprazole
Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI
Interventions
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Clarithromycin+ Amoxicillin + Omeprazole
In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children
Metronidazole +Amoxicillin + Omeprazole
Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
12 Years
ALL
No
Sponsors
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Shaheed Zulfiqar Ali Bhutto Medical University
OTHER
Responsible Party
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Dr.Nadia waheed
Assistant professor
Principal Investigators
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Nadia Waheed
Role: PRINCIPAL_INVESTIGATOR
PIMS, SZABMU,ISLAMABAD
Locations
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Pakistan Institute of Medical Sciences,SZABMU
Islamabad, Capital Territory, Pakistan
Pakistan Institute of Medical Sciences, Islamabad
Islamabad, Islamabad, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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F-.1-1/2015/ERB/SZABMU/646
Identifier Type: -
Identifier Source: org_study_id
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