NCT06986148

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 12 Months – 71 Months
• Healthy volunteers: Not accepted

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.

Detailed 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 patients. Patient recruitment will occur over a 3.5-year period. Participants will be identified and screened during routine visits at the clinical sites. Through an online system, participants will be randomized to either the immediate antibiotic group or the SNAP group. All participants will receive a prescription for antibiotics as per usual care from their treating clinician. The parents or guardians of the participants will be asked to complete an online survey on Days 4 and 14 (+/- 2 days) to collect data for the secondary outcomes, including quality of life, satisfaction, and return visits. On Day 7 (+/- 2 days), the parents or guardians of the participants will be contacted by phone to collect data for the primary outcome, focusing on clinical improvement and antibiotic use. Acceptability and feasibility will be assessed with parent or guardian and clinician surveys and interviews. Parents or guardians will be surveyed at Day 14 and a subset will be invited for interviews within a month of the final follow-up visit. Clinicians will be surveyed, and a subset will be interviewed at the conclusion of the trial.

Conditions

• Community Acquired Pneumonia (CAP)
• Community Acquired Pneumonia

Interventions

Type	Name	Description
OTHER	Immediate 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.
OTHER	Safety 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.

Timeline

• Start date: 2025-09-09
• Primary completion: 2029-06-30
• Completion: 2029-07-16
• First posted: 2025-05-22
• Last updated: 2026-01-27

Locations

4 sites across 1 country: United States