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Short-course Antimicrobial Therapy for Paediatric Respiratory Infections (SAFER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02380352
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : June 8, 2021
Children's Hospital of Eastern Ontario
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

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.

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Amoxicillin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-course Antimicrobial Therapy for Paediatric Respiratory Infections
Study Start Date : September 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Short-course
5 days amoxicillin 90 mg/kg/day divided TID followed by 5 days placebo TID
Drug: Amoxicillin
Other Name: Amoxil

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

Active Comparator: Standard
5 days amoxicillin 90 mg/kg/day divided TID followed by alternate formulation 5 days amoxicillin 90 mg/kg/day divided TID
Drug: Amoxicillin
Other Name: Amoxil

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380352

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Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8S 4K1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Children's Hospital of Eastern Ontario
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Principal Investigator: Jeffrey M Pernica, MD McMaster University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02380352    
Obsolete Identifiers: NCT01707485
Other Study ID Numbers: SAFER 001 PSI
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: May 2021
Keywords provided by Hamilton Health Sciences Corporation:
antibiotic stewardship
randomized controlled trial
Additional relevant MeSH terms:
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Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents