Clinical trial NCT06986148: Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)
Official title: Comparing Antibiotic Treatment Strategies for Children With Community-Acquired Pneumonia in Outpatient Settings (Safety-Net Antibiotic Prescribing to Manage Pediatric Pneumonia [STAMPP])
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Community Acquired Pneumonia (CAP)
Community Acquired Pneumonia
Keywords: Community-acquired Pneumonia
Pediatric Respiratory Diseases
Pneumonia
Antibiotic Use
SNAP
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2025-05-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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 study sites who can comment on the implementation of each prescribing strategy.

Exclusion Criteria:

* Aims 1 and 2:
* Hospitalization within the previous 7 days
* Oxygen saturation below 90%, if measured
* Incomplete immunization status (e.g., lacking at least 2 doses of the pneumococcal vaccines, typically given as part of the 2- and 4-month vaccinations)
* Chronic medical conditions that increase the risk of bacterial CAP (e.g., chronic lung disease, cystic fibrosis, sickle cell disease),\\
* Substantially immunocompromised status (e.g., immunodeficiency, active cancer treatment, organ transplant with concurrent immunosuppressive agents)
* Receipt of oral or parenteral antibiotics within the previous 7 days
* Diagnosis of complicated pneumonia (e.g., empyema, lung abscess)
* Known bacterial source of infection warranting immediate antibiotics
* Pneumonia diagnosis within the previous 6 months, OR
* Prior enrollment in the trial
* Inability of the parent or guardian to speak English or Spanish
* Aim 3:
* Inability of the parent or guardian to speak English

Primary outcomes:
measure: Clinical Improvement
timeFrame: From enrollment to day 7
measure: Antibiotic Use
timeFrame: From enrollment to day 7
Secondary outcomes:
measure: Antibiotic Exposure
timeFrame: From enrollment to day 14
measure: Clinical Improvement
timeFrame: From enrollment to day 14
measure: Parent Satisfaction
timeFrame: From enrollment to day 14
measure: Quality of Life Measures
timeFrame: From enrollment to day 14
measure: Return to Care
timeFrame: From enrollment to day 14
Other outcomes:
measure: Antibiotic-associated Adverse Events
timeFrame: From enrollment to day 14
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Todd Florin, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Julia Szymczak, PhD
role: PRINCIPAL_INVESTIGATOR
References: