Comparison of Efficacy of Triple Regimen Based on Clarithromycin VS Metronidazole in Children (CETR)
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| ClinicalTrials.gov Identifier: NCT04721704 |
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Recruitment Status :
Recruiting
First Posted : January 25, 2021
Last Update Posted : January 26, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| H Pylori Gastritis | Drug: Clarithromycin+ Amoxicillin + Omeprazole Drug: Metronidazole +Amoxicillin + Omeprazole | Not Applicable |
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 1.8 % 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 31.8% resistance rate to clarithromycin and 25.7% 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 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of Efficacy and Safety of Triple Regimen Based on Clarithromycin VS Metronidazole in Pediatric Population in Pakistan |
| Actual Study Start Date : | September 14, 2020 |
| Estimated Primary Completion Date : | September 14, 2022 |
| Estimated Study Completion Date : | September 14, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group A
Group A will be given Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI based triple regimen
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Drug: Clarithromycin+ Amoxicillin + Omeprazole
In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children
Other Name: Klaricid + Amoxil + Risek |
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Experimental: Group B
Group B will be given Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI based triple regimen
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Drug: Metronidazole +Amoxicillin + Omeprazole
Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI
Other Name: Flagyl + Amoxil + Risek |
- Efficacy of Clarithromycin vs Metronidazole based triple regimen in treatment of H-pylori in induced Acid peptic disease in children in terms of reduction in duration of symptoms and negative Stool H-Pylori-Ag [ Time Frame: 2 weeks ]All children age 1-12 years diagnosed with acid peptic disease with positive H-pylori Ag in stool will be randomized in to Group A & Group B and will be given either CLA or MET based triple eradication regimen. After 4 weeks of complication of triple regimen patients form both groups will be re-tested for H-pylori Ag in stool. The efficacy of both regimen will be compare in terms of duration of resolution of symptoms of Acid peptic disease and number of patients having negative stool H pylori Ag post treatment.
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| Ages Eligible for Study: | 1 Year to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1. All children age 1-12 years having H-pylori gastritis
Exclusion Criteria:
- drug induced gastritis critically ill child
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721704
| Contact: Nadia Waheed | 923334461116 | drnadiasalman@gmail.com | |
| Contact: Nighat Haider | 923212125768 | nighathaider@hotmail.com |
| Pakistan | |
| Pakistan Institute of Medical Sciences,SZABMU | Recruiting |
| Islamabad, Capital Territory, Pakistan, 44000 | |
| Contact: Nadia W,aheed, FCPS 923334461116 drnadiasalman@gmail.com | |
| Contact: Nighat Haider, FCPS 923212125768 nighathaider@hotmail.com | |
| Principal Investigator: Jai Krishin, FCPS | |
| Pakistan Institute of Medical Sciences, Islamabad | Recruiting |
| Islamabad, Islamabad Capital Territory, Pakistan, 44000 | |
| Contact: Nadia W,aheed, FCPS 923334461116 drnadiasalman@gmail.com | |
| Contact: Nighat Haider, FCPS 923212125768 nighathaider@hotmail.com | |
| Principal Investigator: Jai Krishin, FCPS | |
| Principal Investigator: | Nadia Waheed | PIMS, SZABMU,ISLAMABAD |
| Responsible Party: | Dr.Nadia waheed, Assistant professor, Shaheed Zulfiqar Ali Bhutto Medical University |
| ClinicalTrials.gov Identifier: | NCT04721704 |
| Other Study ID Numbers: |
F-.1-1/2015/ERB/SZABMU/646 |
| First Posted: | January 25, 2021 Key Record Dates |
| Last Update Posted: | January 26, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | SPSS DATA SHEETS WILL BE SHARED |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | 6 months after publication for further 6 months |
| Access Criteria: | through email on demand |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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H-pylori gastritis, eradication therapy, triple regimen |
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Gastritis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Amoxicillin Metronidazole Clarithromycin Omeprazole Anti-Bacterial Agents Anti-Infective Agents |
Antiprotozoal Agents Antiparasitic Agents Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |