Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

Hamilton Health Sciences Corporation2 sites in 1 country281 target enrollmentSeptember 2016

ConditionsCommunity-acquired Pneumonia

InterventionsAmoxicillin Placebo

DrugsAmoxicillin Placebo

Overview

Phase: Phase 4
Intervention: Amoxicillin
Conditions: Community-acquired Pneumonia
Sponsor: Hamilton Health Sciences Corporation
Enrollment: 281
Locations: 2
Primary Endpoint: Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

April 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hamilton Health Sciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric criteria are met:
•fever (\>37.5 C axillary, \> 37.7 C oral, or \>38 C rectal) recorded in the ED or at home in the 48h prior to presentation;
•any one of:
•tachypnoea on exam (\>60 bpm for age \<1 y, \>50 bpm for 1-2 y of age, \>40 bpm for 2-4 y of age, and \>30 bpm for \>4 y of age);
•cough on exam or by history;
•increased work of breathing on exam; or
•auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia;
•infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and
•the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet inclusion criteria.)
•Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation \> 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph.

Exclusion Criteria

•Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (\>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of \> 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin \< 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once.