RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Community Acquired Pneumonia (CAP)
Intervention / Treatment

-

Contacts and Locations

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30329

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Salt Lake City

Primary Children's Hospital, 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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

12 Months to 71 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2029-07-16