Comparing Antibiotic Treatment Strategies for Children With Community-Acquired Pneumonia in Outpatient Settings (Safety-Net Antibiotic Prescribing to Manage Pediatric Pneumonia [STAMPP])

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 5
Healthy Volunteers: f
View:

• 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 study sites who can comment on the implementation of each prescribing strategy.

Locations
United States
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Pennsylvania
Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Contact Information
Primary
Todd Florin, MD, MSCE
taflorin@luriechildrens.org
312-227-6675
Backup
Julia Szymczak, PhD
julia.szymczak@hsc.utah.edu
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2029-07-16
Participants
Target number of participants: 2000
Treatments
Active_comparator: Immediate Antibiotic Prescribing
For participants randomized to this arm, a prescription is filled and the antibiotic is administered right after the index visit.
Other: Safety Net Antibiotic Prescribing (SNAP)
For participants randomized to this arm, a prescription is provided, but the patient is instructed not to take the antibiotic unless the child is not improving at 72 hours or sooner if getting worse.
Related Therapeutic Areas
Sponsors
Leads: Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov