Antibiotic strategies for young children with pneumonia in outpatient care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, hybrid effectiveness-implementation randomized trial will enroll up to 2,000 outpatient children aged 12 months to under 6 years diagnosed with mild community-acquired pneumonia across about 19 US sites including pediatric emergency departments, primary care offices, and urgent care centers. Participants are randomized via an online system to either immediate antibiotic prescribing or SNAP, where parents receive a prescription but are instructed to start antibiotics only if the child is not improving after 72 hours or worsens sooner. All participants receive usual-care prescriptions and outcome data are collected by a phone call on day 7 and parent surveys on days 4 and 14 to capture clinical improvement, antibiotic use, quality of life, satisfaction, and return visits. The trial also gathers clinician and parent feedback to measure acceptability and feasibility of implementing each prescribing strategy in routine practice.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Todd Florin, MD, MSCE — Ann & Robert H Lurie Children's Hospital of Chicago
• Study coordinator: Todd Florin, MD, MSCE
• Email: taflorin@luriechildrens.org
• Phone: 312-227-6675

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.