Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)
STAMPP
2 other identifiers
interventional
2,000
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2025
CompletedFirst Posted
Study publicly available on registry
May 22, 2025
CompletedStudy Start
First participant enrolled
September 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 16, 2029
January 27, 2026
January 1, 2026
3.8 years
May 7, 2025
January 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Improvement
Clinical improvement at 7 days after the index visit, defined as parent-reported (a) perception of overall improvement, (b) no worsening of fever, work of breathing, concerning changes in activity, or decreased oral intake, (c) no new antibiotic use or hospitalization following the index visit, and (d) improvement in at least one key pneumonia symptom in (b).
From enrollment to day 7
Antibiotic Use
Antibiotic use through 7 days after the index visit, defined as Parent-reported antibiotic use (yes/no) at 7 days.
From enrollment to day 7
Secondary Outcomes (5)
Antibiotic Exposure
From enrollment to day 14
Clinical Improvement
From enrollment to day 14
Parent Satisfaction
From enrollment to day 14
Quality of Life Measures
From enrollment to day 14
Return to Care
From enrollment to day 14
Other Outcomes (1)
Antibiotic-associated Adverse Events
From enrollment to day 14
Study Arms (2)
Immediate Antibiotic Prescribing
ACTIVE COMPARATORFor participants randomized to this arm, a prescription is filled and the antibiotic is administered right after the index visit.
Safety Net Antibiotic Prescribing (SNAP)
OTHERFor 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.
Interventions
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.
Children randomized to the immediate antibiotic prescribing group will receive an antibiotic prescription with instructions to fill and administer the antibiotics.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Aims 1 and 2:
- 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),
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Primary Children's Hospital
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Florin, MD, MSCE
Ann & Robert H Lurie Children's Hospital of Chicago
- PRINCIPAL INVESTIGATOR
Julia Szymczak, PhD
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Division Head for Academic Affairs & Research, Division of Emergency Medicine
Study Record Dates
First Submitted
May 7, 2025
First Posted
May 22, 2025
Study Start
September 9, 2025
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
July 16, 2029
Last Updated
January 27, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
At the conclusion of the study, a de-identified dataset will be prepared and made available for sharing with investigators as specified by the lead investigators and the funding agency. Data sharing will follow established guidelines to ensure that any shared dataset does not contain protected health information (PHI) and is fully anonymized. Investigators requesting access to the dataset will need to submit a data use agreement, specifying how the data will be used. Results of the study will be disseminated through peer-reviewed journals, presentations at scientific meetings, and the PCORI website. Aim 3 interview transcripts will not be shared to a publicly available repository since it will be impossible to fully anonymize the transcripts.