Antibiotic strategies for young children with pneumonia in outpatient care
Comparing Antibiotic Treatment Strategies for Children With Community-Acquired Pneumonia in Outpatient Settings (Safety-Net Antibiotic Prescribing to Manage Pediatric Pneumonia [STAMPP])
This trial will see if a 'watch-and-wait' Safety Net Antibiotic Prescribing (SNAP) approach can safely reduce antibiotic use compared with immediate antibiotics in children aged 12 months to under 6 years with mild community-acquired pneumonia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 12 Months to 71 Months |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT06986148 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children 12 months to under 6 years diagnosed with mild community-acquired pneumonia for whom the treating clinician intends outpatient antibiotic prescribing and who are well enough to be managed at home.
Not a fit: Children who were recently hospitalized, have low oxygen saturation, have incomplete immunizations, significant chronic medical conditions, or more severe pneumonia are unlikely to benefit from the SNAP approach in this trial.
Why it matters
Potential benefit: If successful, the SNAP approach could lower unnecessary antibiotic use, reduce side effects and antibiotic resistance, and allow most children to recover without immediate antibiotics.
How similar studies have performed: Delayed or safety-net antibiotic prescribing has reduced antibiotic use for other pediatric respiratory infections like otitis media and bronchitis, but randomized evidence specifically for outpatient pediatric pneumonia is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Atlanta, Georgia and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.