NCT06986148 · Ann & Robert H Lurie Children's Hospital of Chicago
Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)
(STAMPP)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Immediate Antibiotic Prescribing Group Instructions
Children randomized to the immediate antibiotic prescribing group will receive an antibiotic prescription with instructions to fill and administer the antibiotics.
OTHER
Safety Net Antibiotic Prescribing (SNAP) Group Instructions
For children randomized to the SNAP group, their parents or guardians will receive a prescription for antibiotics, but will be told not to administer the antibiotic unless their child's symptoms show no improvement at 72 hours or worsen within 72 hours.
Primary outcome measures
Clinical Improvement
Time frame: From enrollment to day 7
Clinical improvement at 7 days after the index visit, defined as parent-reported (a) perception of overall improvement, (b) no worsening of fever, work of breathing, concerning changes in activity, or decreased oral intake, (c) no new antibiotic use or hospitalization following the index visit, and (d) improvement in at least one key pneumonia symptom in (b).
Antibiotic Use
Time frame: From enrollment to day 7
Antibiotic use through 7 days after the index visit, defined as Parent-reported antibiotic use (yes/no) at 7 days.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
- Inability of the parent or guardian to speak English
Where
- Atlanta, Georgia
- Chicago, Illinois
- Philadelphia, Pennsylvania
- Salt Lake City, Utah
Collaborators
Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2026 · Source of record for eligibility and locations