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

NCT04721704 | Unknown DMC

• 1 other identifier: F-.1-1/2015/ERB/SZABMU/646
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

H Pylori Gastritis

Keywords

H-pylori gastritis, eradication therapy, triple regimen

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

Group A

EXPERIMENTAL

Group A will be given Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI based triple regimen

Drug: Clarithromycin+ Amoxicillin + Omeprazole

Group B

EXPERIMENTAL

Group B will be given Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI based triple regimen

Drug: Metronidazole +Amoxicillin + Omeprazole

Interventions

Clarithromycin+ Amoxicillin + Omeprazole DRUG

In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children

Also known as: Klaricid + Amoxil + Risek

Group A

Metronidazole +Amoxicillin + Omeprazole DRUG

Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI

Also known as: Flagyl + Amoxil + Risek

Group B

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• drug induced gastritis critically ill child

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (2)

Pakistan Institute of Medical Sciences,SZABMU

Islamabad, Capital Territory, 44000, Pakistan

RECRUITING

Pakistan Institute of Medical Sciences, Islamabad

Islamabad, Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Interventions

Omeprazole; Clarithromycin; Amoxicillin; Metronidazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Nadia Waheed

  PIMS, SZABMU,ISLAMABAD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Waheed

CONTACT

923334461116; drnadiasalman@gmail.com

Nighat Haider

CONTACT

923212125768; nighathaider@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 25, 2021
• Study Start: September 14, 2020
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication for further 6 months
• Access Criteria: through email on demand

Locations

PA (2)