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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02380352
Other study ID # SAFER 001 PSI
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2016
Est. completion date April 2020

Study information

Verified date May 2021
Source Hamilton Health Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT01707485

Recruitment information / eligibility

Status Completed
Enrollment 281
Est. completion date April 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 6 Months to 10 Years
Eligibility 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.

Study Design


Intervention

Drug:
Amoxicillin

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

Locations

Country Name City State
Canada McMaster Children's Hospital Hamilton Ontario
Canada Children's Hospital of Eastern Ontario Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever) Resolution of tachypnoea, increased work of breathing, and fever at 14-21 days post-enrolment
Secondary Days of adverse reactions up to 14 days post-enrolment
Secondary Days of missed school up to 14 days post-enrolment
Secondary Days of missed/disrupted work for caregiver(s) up to 14 days post-enrolment
Secondary Adherence to study medications up to 10 days post-enrolment
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