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

January 24, 2026 updated by: Todd A. Florin, Ann & Robert H Lurie Children's Hospital of Chicago

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
        • Principal Investigator:
          • Claudia Morris, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Todd Florin, MD, MSCE
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Principal Investigator:
          • Jeffrey Gerber, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathleen Chiotos, MD, MSCE
        • Principal Investigator:
          • Laura Sartori, MD, MPH
    • Utah
      • Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate Antibiotic Prescribing
For participants randomized to this arm, a prescription is filled and the antibiotic is administered right after the index visit.
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)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Improvement
Time Frame: From enrollment to day 7
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
Time Frame: From enrollment to day 7
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic Exposure
Time Frame: From enrollment to day 14
Antibiotic exposure, defined as the number of days antibiotics were consumed through day 7 and day 14.
From enrollment to day 14
Parent Satisfaction
Time Frame: From enrollment to day 14
Parent-reported satisfaction with the treatment strategy at day 14. Parent-reported satisfaction with the treatment strategy is assessed on an ordinal scale with "Very Dissatisfied" as the minimum measurement and "Very Satisfied" as the maximum measurement.
From enrollment to day 14
Quality of Life Measures
Time Frame: From enrollment to day 14
Quality of life, defined by parent/guardian using the Pediatric Quality of Life Inventory (PedsQL) at days 7 and 14
From enrollment to day 14
Return to Care
Time Frame: From enrollment to day 14
Parent-reported return to medical care after index visit and reason for return
From enrollment to day 14
Clinical Improvement
Time Frame: From enrollment to day 14
Clinical improvement at day 4 and day 14. Clinical improvement is defined as parent-reported perception of overall improvement, no worsening of fever, work of breathing, concerning changes in activity, or decreased oral intake, no new antibiotic use or hospitalization following the index visit, and improvement in at least one of these key pneumonia symptoms. Symptom improvement is assessed on an ordinal scale with "Much Worse" as the minimum measurement and "Much Better" as the maximum measurement.
From enrollment to day 14

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic-associated Adverse Events
Time Frame: From enrollment to day 14
Rash, diarrhea, diaper dermatitis, oral thrush, vomiting, anaphylaxis
From enrollment to day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Todd Florin, MD, MSCE, Ann & Robert H Lurie Children's Hospital of Chicago
  • Principal Investigator: Julia Szymczak, PhD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2025

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

July 16, 2029

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 20, 2025

First Posted (Actual)

May 22, 2025

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00185848
  • BPS-2023C3-35456 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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