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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-course treatment | Experimental | 5 days of placebo (after participants already received 3-5 days of antibiotics) |
|
| Standard-duration treatment | Active Comparator | 5 days of amoxicillin (after participants already received 3-5 days of antibiotics) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 5 days of placebo to be given after 3-5 days of antibiotics |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Consent success | The proportion of potentially eligible participants who consent | Day 0 |
| Open-label antibiotic use | The proportion of participants who receive open-label (non-study) antibiotics | before Day 30 |
| Losses to followup | The proportion of participants lost to follow-up | before Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with late clinical response | 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 | Day 15 |
| Proportion of participants with repeat hospitalization for CAP |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Pernica, MD | Contact | 9055212100 | 77577 | pernica@mcmaster.ca |
| Shamini Selvakumar, MD | Contact | 9055212100 | selvaks@mcmaster.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Children's Hospital | Recruiting | Hamilton | Ontario | L8S 4K1 | Canada |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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Participants in all arms will receive 5 days of study medications.
| Amoxicillin |
| Drug |
Standard-dose amoxicillin (approved by Health Canada) to be given x 5 days. |
|
| 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 | Complicated defined by effusion, empyaema, necrotizing pneumonia | before Day 30 |
| D012140 |
| Respiratory Tract Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |