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

Recruiting now · Not applicable

Conditions studied: Community Acquired Pneumonia (CAP), Community Acquired Pneumonia

In brief

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.

Key facts

Study ID

NCT06986148

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

2000

Starts

2025-09-09

Expected to finish

2029-07-16

Last updated by the study team

2026-01-27

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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