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Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

NCT02380352 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2021-06-08

No results posted yet for this study

Summary

Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.

Conditions

  • Community-acquired Pneumonia

Interventions

DRUG

Amoxicillin

DRUG

Placebo

Experimental arm must receive 5 days placebo after 5 days amoxicillin to preserve blinding.

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Jeffrey M Pernica, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-12-31
Completion
2020-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02380352 on ClinicalTrials.gov