RECRUITING

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

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Conditions

Community Acquired Pneumonia (CAP)Community Acquired PneumoniaCommunity-acquired PneumoniaPediatric Respiratory DiseasesPneumoniaAntibiotic UseSNAP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-30
Study Completion:2029-07-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06986148

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.

Ages Eligible for Study:12 Months to 71 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Aims 1 and 2:
  2. * Presenting with signs and symptoms of lower respiratory tract infection
  3. * Diagnosed with community-acquired pneumonia (CAP) by a clinician
  4. * The treating clinician intends to prescribe antibiotics for CAP, AND
  5. * Well enough, as determined by the clinician at the time of the study enrollment visit, to be managed as an outpatient.
  6. * Aim 3:
  7. * Parent/guardian of child enrolled in the trial, OR
  8. * Clinician who makes prescribing decision at the study site, OR
  9. * 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.
  1. * Aims 1 and 2:
  2. * Hospitalization within the previous 7 days
  3. * Oxygen saturation below 90%, if measured
  4. * 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)
  5. * Chronic medical conditions that increase the risk of bacterial CAP (e.g., chronic lung disease, cystic fibrosis, sickle cell disease),\\
  6. * Substantially immunocompromised status (e.g., immunodeficiency, active cancer treatment, organ transplant with concurrent immunosuppressive agents)
  7. * Receipt of oral or parenteral antibiotics within the previous 7 days
  8. * Diagnosis of complicated pneumonia (e.g., empyema, lung abscess)
  9. * Known bacterial source of infection warranting immediate antibiotics
  10. * Pneumonia diagnosis within the previous 6 months, OR
  11. * Prior enrollment in the trial
  12. * Inability of the parent or guardian to speak English or Spanish
  13. * Aim 3:
  14. * Inability of the parent or guardian to speak English

Contacts and Locations

Study Contact

Todd Florin, MD, MSCE
CONTACT
312-227-6675
taflorin@luriechildrens.org
Julia Szymczak, PhD
CONTACT
julia.szymczak@hsc.utah.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

  • Todd Florin, MD, MSCE, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago
  • Julia Szymczak, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-08-30
Study Completion Date2029-07-16

Study Record Updates

Study Start Date2025-08-30
Study Completion Date2029-07-16

Terms related to this study

Keywords Provided by Researchers

  • Community-acquired Pneumonia
  • Pediatric Respiratory Diseases
  • Pneumonia
  • Antibiotic Use
  • SNAP

Additional Relevant MeSH Terms

  • Community Acquired Pneumonia (CAP)
  • Community Acquired Pneumonia