Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)
NCT ID: NCT06986148
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2025-09-09
2029-07-16
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Immediate Antibiotic Prescribing
For participants randomized to this arm, a prescription is filled and the antibiotic is administered right after the index visit.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Months
71 Months
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Responsible Party
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Todd A. Florin
Associate Division Head for Academic Affairs & Research, Division of Emergency Medicine
Principal Investigators
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Todd Florin, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Julia Szymczak, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BPS-2023C3-35456
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB_00185848
Identifier Type: -
Identifier Source: org_study_id
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