PRESTO-2: Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Short-course treatment 5 days of placebo (after participants already received 3-5 days of antibiotics) |
Drug: Placebo
5 days of placebo to be given after 3-5 days of antibiotics
|
| Active Comparator: Standard-duration treatment 5 days of amoxicillin (after participants already received 3-5 days of antibiotics) |
Drug: Amoxicillin
Standard-dose amoxicillin (approved by Health Canada) to be given x 5 days.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 with repeat hospitalization for CAP [before Day 30]
- Proportion of participants with drug-related AEs (any severity) [before Day 30]
- 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 unscheduled primary care visits [before Day 30]
- Proportion of participants who develop complicated pneumonia [before Day 30]
Complicated defined by effusion, empyaema, necrotizing pneumonia
Eligibility Criteria
Criteria
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:
-
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 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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jeffrey Pernica
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HHS-CB 2023-Pernica-2