Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

Community-acquired Pneumonia Clinical Trial

— SAFER  

Official title:

Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380352
• Other study ID #: SAFER 001 PSI
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia
• Respiratory Tract Infections

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