NCT06986148 Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)
| NCT ID | NCT06986148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Condition | Community Acquired Pneumonia (CAP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2025-09-09 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Todd Florin, MD, MSCE
PRINCIPAL INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Frequently Asked Questions
Who can join the NCT06986148 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 71 Months, studying Community Acquired Pneumonia (CAP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06986148 currently recruiting?
Yes, NCT06986148 is actively recruiting participants. Contact the research team at taflorin@luriechildrens.org for enrollment information.
Where is the NCT06986148 trial being conducted?
This trial is being conducted at Atlanta, United States, Chicago, United States, Philadelphia, United States, Salt Lake City, United States.
Who is sponsoring the NCT06986148 clinical trial?
NCT06986148 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Todd Florin, MD, MSCE at Ann & Robert H Lurie Children's Hospital of Chicago. The trial plans to enroll 2,000 participants.