Community-acquired Pneumonia
Conditions
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 adults hospitalized with CAP - but there is very little evidence in children. We intend to do a pilot RCT of short-course (3-5 days) vs standard-duration (8-10 days) antibiotic therapy for children hospitalized for CAP.
Interventions
DRUGPlacebo
5 days of placebo to be given after 3-5 days of antibiotics
DRUGAmoxicillin
Standard-dose amoxicillin (approved by Health Canada) to be given x 5 days.
Sponsors
Jeffrey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants in all arms will receive 5 days of study medications.
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* \- 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: 1. 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); 2. cough on exam or by history; 3. increased work of breathing on exam; or 4. auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent success | Day 0 | The proportion of potentially eligible participants who consent |
| Open-label antibiotic use | before Day 30 | The proportion of participants who receive open-label (non-study) antibiotics |
| Losses to followup | before Day 30 | The proportion of participants lost to follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with serious drug AEs | before Day 30 | — |
| Proportion of participants with unscheduled ED or urgent care visits | before Day 30 | — |
| Proportion of participants with late clinical response | Day 15 | LCR is defined as: i) clinical improvement in fever, work of breathing, oral intake, and activity level, AND ii) lack of receipt of additional antimicrobials |
| Proportion of participants who develop complicated pneumonia | before Day 30 | Complicated defined by effusion, empyaema, necrotizing pneumonia |
| Proportion of participants with unscheduled primary care visits | before Day 30 | — |
| Proportion of participants with repeat hospitalization for CAP | before Day 30 | — |
| Proportion of participants with drug-related AEs (any severity) | before Day 30 | — |
Countries
Canada
Contacts
Primary ContactJeffrey Pernica, MD
Backup ContactShamini Selvakumar, MD
Outcome results
None listed