Comparing Antibiotic Treatment Strategies for Children With Community-Acquired Pneumonia in Outpatient Settings (Safety-Net Antibiotic Prescribing to Manage Pediatric Pneumonia [STAMPP])
Ann & Robert H Lurie Children's Hospital of Chicago
Summary
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.
Description
This study is a multicenter, Hybrid Type-1effectiveness-implementation randomized clinical trial (RCT) designed to evaluate the effectiveness of a "Safety Net Antibiotic Prescribing" (SNAP) strategy versus an immediate antibiotic prescribing strategy for young children 12 months to \<6 years of age with community-acquired pneumonia (CAP) who are treated as outpatients. This study will recruit eligible patients from approximately 19 clinical sites consisting of pediatric emergency departments (EDs), primary care offices, and urgent care centers within the United States and enroll up to 2,000 p…
Eligibility
- Age range
- 1–5 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aims 1 and 2: * 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. * Aim 3: * Parent/guardian of child enrolled in the trial, OR * Clinician who makes prescribing decision at the study site, OR * Other practice-based parties (e.g. nurses, pharmacists, medical assistants, practice leaders) at stud…
Interventions
- OtherImmediate Antibiotic Prescribing Group Instructions
Children randomized to the immediate antibiotic prescribing group will receive an antibiotic prescription with instructions to fill and administer the antibiotics.
- OtherSafety Net Antibiotic Prescribing (SNAP) Group Instructions
For 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.
Locations (4)
- Children's Healthcare of AtlantaAtlanta, Georgia
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- Primary Children's HospitalSalt Lake City, Utah