Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04721704
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2021-01-16
Brief Title:
Comparison of Efficacy of Triple Regimen Based on Clarithromycin VS Metronidazole in Children
Sponsor:
Shaheed Zulfiqar Ali Bhutto Medical University
Organization:
Shaheed Zulfiqar Ali Bhutto Medical University
Study Overview
Official Title:
Comparison of Efficacy and Safety of Triple Regimen Based on Clarithromycin VS Metronidazole in Pediatric Population in Pakistan
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CETR
Brief Summary:
All children from 1day to 18years of age diagnosed with peptic ulcer disease due to H pylori at Pakistan Institute of Medical Sciences Islamabad from July 2020 to December 2021 will be included in the study After informed written consent from parents guardians patients bio data along with history and examination will be recorded on a proforma They will be allocated into two groups group A and group B randomly based on treatment regimen offered
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
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
Detailed Description:
Helicobacter pylori is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide1 In general the prevalence is high in developing countries and the infection is acquired at a young age Most children infected with H pylori are asymptomatic Antral gastritis is the most common manifestation in children Duodenal and gastric ulcers may be associated with H pylori gastritis in 18 children2 Antibiotic resistance is the major cause of failure in the treatment of H pylori infection3 Most of the studies worldwide confirmed an increase in macrolide resistance while metronidazole resistance either decreased or remained stable In a prospective multicenter European study primarily comprised of adults found a 318 resistance rate to clarithromycin and 257 to metronidazole in the study4
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 NutritionNorth 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 nationalregional 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
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 NutritionNorth 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 nationalregional 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None