Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-71
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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),

Trial design

Treatments tested in this trial

  • Immediate Antibiotic Prescribing Group Instructions
  • Safety Net Antibiotic Prescribing (SNAP) Group Instructions

Treatment groups

2,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator