Clinical trial NCT02380352: Short-course Antimicrobial Therapy for Paediatric Respiratory Infections
Official title: Short-course Antimicrobial Therapy for Paediatric Respiratory Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Community-acquired Pneumonia
Keywords: antibiotic stewardship
non-inferiority
randomized controlled trial
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Eastern Ontario
First posted: 2015-03-05
Enrollment: 281
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

1. 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;
2. any one of:

   1. 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);
   2. cough on exam or by history;
   3. increased work of breathing on exam; or
   4. auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia;
3. infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and
4. 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.

Primary outcomes:
measure: Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever)
timeFrame: at 14-21 days post-enrolment
Secondary outcomes:
measure: Days of adverse reactions
timeFrame: up to 14 days post-enrolment
measure: Days of missed school
timeFrame: up to 14 days post-enrolment
measure: Days of missed/disrupted work for caregiver(s)
timeFrame: up to 14 days post-enrolment
measure: Adherence to study medications
timeFrame: up to 10 days post-enrolment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: McMaster University
name: Jeffrey M Pernica, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pernica JM, Harman S, Kam AJ, Carciumaru R, Vanniyasingam T, Crawford T, Dalgleish D, Khan S, Slinger RS, Fulford M, Main C, Smieja M, Thabane L, Loeb M. Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):475-482. doi: 10.1001/jamapediatrics.2020.6735.
citation: Pernica J, Harman S, Kam A, Bailey J, Carciumaru R, Khan S, Fulford M, Thabane L, Slinger R, Main C, Smieja M, Loeb M. Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial. Trials. 2018 Feb 1;19(1):83. doi: 10.1186/s13063-018-2457-2.