Status:
RECRUITING
Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Community Acquired Pneumonia (CAP)
Community Acquired Pneumonia
Eligibility:
All Genders
12-71 years
Phase:
NA
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 ...
Detailed Description
This study is a multicenter, Hybrid Type-1effectiveness-implementation randomized clinical trial (RCT) designed to evaluate the effectiveness of a "Safety Net Antibiotic Prescribing" (SNAP) strategy v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 16 2029
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06986148
Start Date
September 9 2025
End Date
July 16 2029
Last Update
September 11 2025
Active Locations (4)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
2
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Primary Children's Hospital
Salt Lake City, Utah, United States, 84108