The goal of this clinical trial is to determine if a "watch and wait" antibiotic strategy, called Safety Net Antibiotic Prescribing (SNAP), can safely reduce unnecessary antibiotic use while ensuring that children diagnosed with community-acquired pneumonia get better from their illness. The main aims of this study are:
* To compare the effectiveness of SNAP versus immediate antibiotic prescribing in children with mild community-acquired pneumonia (CAP) * To identify which patient groups benefit most from the SNAP strategy * To identify factors that shape implementation of each prescribing strategy.
Researchers will compare the SNAP strategy (where parents or guardians are instructed to give antibiotics only if their child is not improving after 72 hours, or sooner if they are worsening) to the immediate antibiotic prescribing strategy (where parents or guardians are instructed to give the antibiotics right after their healthcare visit) to see if one strategy is more effective than the other.
Participants will be randomly assigned to either the immediate antibiotic group or the SNAP group at enrollment. Participation lasts 14 days with follow-up surveys at 4, 7, and 14 days after enrollment.
Presenting with signs and symptoms of lower respiratory tract infection
Diagnosed with community-acquired pneumonia (CAP) by a clinician
The treating clinician intends to prescribe antibiotics for CAP, AND
Well enough, as determined by the clinician at the time of the study enrollment visit, to be managed as an outpatient.
Hospitalization within the previous 7 days
Oxygen saturation below 90%, if measured
Incomplete immunization status (e.g., lacking at least 3 doses of the pneumococcal vaccines, typically given as part of the 2-, 4-, and 6-month vaccinations)
Chronic medical conditions that increase the risk of bacterial CAP (e.g., chronic lung disease, cystic fibrosis, sickle cell disease),
Parallel
Immediate Antibiotic Prescribing Group Instructions
Other interventionChildren randomized to the immediate antibiotic prescribing group will receive an antibiotic prescription with instructions to fill and administer the antibiotics.
Safety Net Antibiotic Prescribing (SNAP) Group Instructions
Other interventionFor children randomized to the SNAP group, their parents or guardians will receive a prescription for antibiotics, but will be told not to administer the antibiotic unless their child's symptoms show no improvement at 72 hours or worsen within 72 hours.
Clinical Improvement
Clinical improvement at 7 days after the index visit, defined as parent-reported (a) perception of overall improvement, (b) no worsening of fever, work of breathing, concerning changes in activity, or decreased oral intake, (c) no new antibiotic use or hospitalization following the index visit, and (d) improvement in at least one key pneumonia symptom in (b).
Antibiotic Use
Antibiotic use through 7 days after the index visit, defined as Parent-reported antibiotic use (yes/no) at 7 days.
Antibiotic Exposure
Antibiotic exposure, defined as the number of days antibiotics were consumed through day 7 and day 14.
Clinical Improvement
Clinical improvement at day 4 and day 14. Clinical improvement is defined as parent-reported perception of overall improvement, no worsening of fever, work of breathing, concerning changes in activity, or decreased oral intake, no new antibiotic use or hospitalization following the index visit, and improvement in at least one of these key pneumonia symptoms. Symptom improvement is assessed on an ordinal scale with "Much Worse" as the minimum measurement and "Much Better" as the maximum measurement.
Parent Satisfaction
Parent-reported satisfaction with the treatment strategy at day 14. Parent-reported satisfaction with the treatment strategy is assessed on an ordinal scale with "Very Dissatisfied" as the minimum measurement and "Very Satisfied" as the maximum measurement.
Quality of Life Measures
Quality of life, defined by parent/guardian using the Pediatric Quality of Life Inventory (PedsQL) at days 7 and 14
Antibiotic-associated Adverse Events
Rash, diarrhea, diaper dermatitis, oral thrush, vomiting, anaphylaxis
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Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
