Status:
RECRUITING
Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy
Lead Sponsor:
Jeffrey
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adult...
Eligibility Criteria
Inclusion
- \- children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:
- documented tachypnoea (\>60 bpm for age \<1 y, \>50 bpm for 1-2 y, \>40 bpm for 2-4 y, and \>30 bpm for \>4 y);
- cough on exam or by history;
- increased work of breathing on exam; or
- auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.
Exclusion
- Children will be excluded if: antibiotics have been discontinued; they received \>3 days of effective antibiotic treatment (excluding macrolide treatment) prior to hospitalization; there is supplemental oxygen use or fever within the past 24 h; more than 5 days elapsed since admission; the attending clinical team does not wish to use oral amoxicillin for treatment (because of allergy or any other reason); or the child is taking coumadin-based anticoagulants or tetracycline-type antibiotics (because of potential interactions with amoxicillin). Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06125340
Start Date
April 17 2024
End Date
January 1 2026
Last Update
December 12 2024
Active Locations (1)
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1
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8S 4K1