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Completed

NCT Number: NCT02380352

Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

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.

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Key information

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McMaster Children's Hospital, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amoxicillin

Drug

Other names: Amoxil

Placebo

Drug

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

Primary outcomes

  1. Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever)

    Time frame: at 14-21 days post-enrolment

    Resolution of tachypnoea, increased work of breathing, and fever

Secondary outcomes

  1. Days of adverse reactions

    Time frame: up to 14 days post-enrolment

  2. Days of missed school

    Time frame: up to 14 days post-enrolment

  3. Days of missed/disrupted work for caregiver(s)

    Time frame: up to 14 days post-enrolment

  4. Adherence to study medications

    Time frame: up to 10 days post-enrolment

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Children's Hospital of Eastern Ontario

Registry information

Acronym: SAFER

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 5, 2015
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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