Comparison of Efficacy of Triple Regimen Based on Clarithromycin VS Metronidazole in Children (CETR)

January 22, 2021 updated by: Dr.Nadia waheed, Shaheed Zulfiqar Ali Bhutto Medical University

Comparison of Efficacy and Safety of Triple Regimen Based on Clarithromycin VS Metronidazole in Pediatric Population in Pakistan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Capital Territory
      • Islamabad, Capital Territory, Pakistan, 44000
        • Recruiting
        • Pakistan Institute of Medical Sciences,SZABMU
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jai Krishin, FCPS
    • Islamabad Capital Territory
      • Islamabad, Islamabad Capital Territory, Pakistan, 44000
        • Recruiting
        • Pakistan Institute of Medical Sciences, Islamabad
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jai Krishin, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. All children age 1-12 years having H-pylori gastritis

Exclusion Criteria:

  • drug induced gastritis critically ill child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A will be given Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI based triple regimen
Drug: Clarithromycin+ Amoxicillin + Omeprazole
In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children
Other Names:
  • Klaricid + Amoxil + Risek
Experimental: Group B
Group B will be given Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI based triple regimen
Drug: Metronidazole +Amoxicillin + Omeprazole
Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI
Other Names:
  • Flagyl + Amoxil + Risek

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Investigators

  • Principal Investigator: Nadia Waheed, PIMS, SZABMU,ISLAMABAD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Anticipated)

September 14, 2022

Study Completion (Anticipated)

September 14, 2022

Study Registration Dates

First Submitted

January 16, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-.1-1/2015/ERB/SZABMU/646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

SPSS DATA SHEETS WILL BE SHARED

IPD Sharing Time Frame

6 months after publication for further 6 months

IPD Sharing Access Criteria

through email on demand

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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