Community Acquired Pneumonia (CAP)STAMPPNCT06986148
Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)
A study testing Immediate Antibiotic Prescribing Group Instructions and Safety Net Antibiotic Prescribing (SNAP) Group Instructions in people with Community Acquired Pneumonia (CAP) and Community Acquired Pneumonia, run by Ann & Robert H Lurie Children's Hospital of Chicago at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 71 months
- Conditions the study is for
- Community Acquired Pneumonia (CAP), Community Acquired Pneumonia
- What is being tested?
- Immediate Antibiotic Prescribing Group Instructions and Safety Net Antibiotic Prescribing (SNAP) Group Instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Sep 2025to 16 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Julia Szymczak, PhD contact
United States4 sites, 4 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Laura Benedit, 404-785-5437, laura.benedit@choa.org
Claudia Morris, MD
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Anne Lakes, 312-227-2488, alakes@luriechildrens.org
Isheeta Jaria, 312-227-1090, ijaria@luriechildrens.org
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Kellyann Baxendell, 267-289-2906, baxendellk@chop.edu
Jessica Albert, albertj1@chop.edu
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84108
Toni Harbour, 801-587-7430, toni.harbour@hsc.utah.edu
Jessica Jung, jessica.jung@hsc.utah.edu
About this study
Official title: Comparing Antibiotic Treatment Strategies for Children With Community-Acquired Pneumonia in Outpatient Settings (Safety-Net Antibiotic Prescribing to Manage Pediatric Pneumonia [STAMPP])
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.
Read more
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.
Read the 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 versus an immediate antibiotic prescribing strategy for young children 12 months to <6 years of age with community-acquired pneumonia (CAP) who are treated as outpatients.
This study will recruit eligible patients from approximately 19 clinical sites consisting of pediatric emergency departments (EDs), primary care offices, and urgent care centers within the United States and enroll up to 2,000 patients. Patient recruitment will occur over a 3.5-year period. Participants will be identified and screened during routine visits at the clinical sites.
Through an online system, participants will be randomized to either the immediate antibiotic group or the SNAP group. All participants will receive a prescription for antibiotics as per usual care from their treating clinician.
The parents or guardians of the participants will be asked to complete an online survey on Days 4 and 14 (+/- 2 days) to collect data for the secondary outcomes, including quality of life, satisfaction, and return visits. On Day 7 (+/- 2 days), the parents or guardians of the participants will be contacted by phone to collect data for the primary outcome, focusing on clinical improvement and antibiotic use.
Acceptability and feasibility will be assessed with parent or guardian and clinician surveys and interviews. Parents or guardians will be surveyed at Day 14 and a subset will be invited for interviews within a month of the final follow-up visit. Clinicians will be surveyed, and a subset will be interviewed at the conclusion of the trial.
- Being tested
- Immediate Antibiotic Prescribing Group Instructions, Safety Net Antibiotic Prescribing (SNAP) Group Instructions
- Keywords
- Community-acquired Pneumonia, Pediatric Respiratory Diseases, Pneumonia, Antibiotic Use, SNAP
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Antibiotic Prescribing Group InstructionsOther
Children randomized to the immediate antibiotic prescribing group will receive an antibiotic prescription with instructions to fill and administer the antibiotics.
Safety Net Antibiotic Prescribing (SNAP) Group InstructionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Antibiotic Prescribing | Active comparator | For participants randomized to this arm, a prescription is filled and the antibiotic is administered right after the index visit. Receives: Other: Immediate Antibiotic Prescribing Group Instructions |
| Safety Net Antibiotic Prescribing (SNAP) | Other | For participants randomized to this arm, a prescription is provided, but the patient is instructed not to take the antibiotic unless the child is not improving at 72 hours or sooner if getting worse. Receives: Other: Safety Net Antibiotic Prescribing (SNAP) Group Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement
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).
Measured: From enrollment to day 7
Antibiotic Use
Antibiotic use through 7 days after the index visit, defined as Parent-reported antibiotic use (yes/no) at 7 days.
Measured: From enrollment to day 7
Secondary outcomes (5)
Antibiotic Exposure
Antibiotic exposure, defined as the number of days antibiotics were consumed through day 7 and day 14.
Measured: From enrollment to day 14
Clinical Improvement
Clinical improvement at day 4 and day 14. Clinical improvement is defined as parent-reported perception of overall improvement, no worsening of fever, work of breathing, concerning changes in activity, or decreased oral intake, no new antibiotic use or hospitalization following the index visit, and improvement in at least one of these key pneumonia symptoms. Symptom improvement is assessed on an ordinal scale with "Much Worse" as the minimum measurement and "Much Better" as the maximum measurement.
Measured: From enrollment to day 14
Parent Satisfaction
Parent-reported satisfaction with the treatment strategy at day 14. Parent-reported satisfaction with the treatment strategy is assessed on an ordinal scale with "Very Dissatisfied" as the minimum measurement and "Very Satisfied" as the maximum measurement.
Measured: From enrollment to day 14
Quality of Life Measures
Quality of life, defined by parent/guardian using the Pediatric Quality of Life Inventory (PedsQL) at days 7 and 14
Measured: From enrollment to day 14
Return to Care
Parent-reported return to medical care after index visit and reason for return
Measured: From enrollment to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start9 Sep 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion16 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Todd A. Florin, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Todd Florin, MD, MSCE, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoJulia Szymczak, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986148
- Sponsor's protocol ID
- IRB_00185848
- Other IDs
- BPS-2023C3-35456
- Acronym
- STAMPP
- Status last verified
- Jan 2026
- First submitted
- 7 May 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the study, a de-identified dataset will be prepared and made available for sharing with investigators as specified by the lead investigators and the funding agency. Data sharing will follow established guidelines to ensure that any shared dataset does not contain protected health information (PHI) and is fully anonymized. Investigators requesting access to the dataset will need to submit a data use agreement, specifying how the data will be used. Results of the study will be disseminated through peer-reviewed journals, presentations at scientific meetings, and the PCORI website. Aim 3 interview transcripts will not be shared to a publicly available repository since it will be impossible to fully anonymize the transcripts.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Antibiotic Treatment Strategies for Children With Community-Acquired Pneumonia in Outpatient Settings (Safety-Net Antibiotic Prescribing to Manage Pediatric Pneumonia [STAMPP])
- ClinicalTrials.gov ID
- NCT06986148
- Acronym / sponsor ID
- STAMPP / IRB_00185848
- Keywords
- Community-acquired Pneumonia, Pediatric Respiratory Diseases, Pneumonia, Antibiotic Use, SNAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 16 Jul 2029 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 versus an immediate antibiotic prescribing strategy for young children 12 months to <6 years of age with community-acquired pneumonia (CAP) who are treated as outpatients.
This study will recruit eligible patients from approximately 19 clinical sites consisting of pediatric emergency departments (EDs), primary care offices, and urgent care centers within the United States and enroll up to 2,000 patients. Patient recruitment will occur over a 3.5-year period. Participants will be identified and screened during routine visits at the clinical sites.
Through an online system, participants will be randomized to either the immediate antibiotic group or the SNAP group. All participants will receive a prescription for antibiotics as per usual care from their treating clinician.
The parents or guardians of the participants will be asked to complete an online survey on Days 4 and 14 (+/- 2 days) to collect data for the secondary outcomes, including quality of life, satisfaction, and return visits. On Day 7 (+/- 2 days), the parents or guardians of the participants will be contacted by phone to collect data for the primary outcome, focusing on clinical improvement and antibiotic use.
Acceptability and feasibility will be assessed with parent or guardian and clinician surveys and interviews. Parents or guardians will be surveyed at Day 14 and a subset will be invited for interviews within a month of the final follow-up visit. Clinicians will be surveyed, and a subset will be interviewed at the conclusion of the trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Antibiotic Prescribing | Active comparator | Other: Immediate Antibiotic Prescribing Group InstructionsFor participants randomized to this arm, a prescription is filled and the antibiotic is administered right after the index visit. |
| Safety Net Antibiotic Prescribing (SNAP) | Other | Other: Safety Net Antibiotic Prescribing (SNAP) Group InstructionsFor participants randomized to this arm, a prescription is provided, but the patient is instructed not to take the antibiotic unless the child is not improving at 72 hours or sooner if getting worse. |
Who may qualify
- Ages
- 12 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Antibiotic Prescribing Group InstructionsChildren randomized to the immediate antibiotic prescribing group will receive an antibiotic prescription with instructions to fill and administer the antibiotics. | Other | Immediate Antibiotic Prescribing |
| Safety Net Antibiotic Prescribing (SNAP) Group InstructionsFor 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. | Other | Safety Net Antibiotic Prescribing (SNAP) |
Primary outcome
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.
5 secondary outcomes
Antibiotic Exposure
Time frame: From enrollment to day 14
Clinical Improvement
Time frame: From enrollment to day 14
Parent Satisfaction
Time frame: From enrollment to day 14
Quality of Life Measures
Time frame: From enrollment to day 14
Return to Care
Time frame: From enrollment to day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes. At the conclusion of the study, a de-identified dataset will be prepared and made available for sharing with investigators as specified by the lead investigators and the funding agency. Data sharing will follow established guidelines to ensure that any shared dataset does not contain protected health information (PHI) and is fully anonymized. Investigators requesting access to the dataset will need to submit a data use agreement, specifying how the data will be used. Results of the study will be disseminated through peer-reviewed journals, presentations at scientific meetings, and the PCORI website. Aim 3 interview transcripts will not be shared to a publicly available repository since it will be impossible to fully anonymize the transcripts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Szymczak, PhD contact
Todd Florin, MD, MSCE principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Julia Szymczak, PhD principal investigator
University of Utah
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Antibiotic Prescribing Group Instructions and Safety Net Antibiotic Prescribing (SNAP) Group Instructions in people with Community Acquired Pneumonia (CAP) and Community Acquired Pneumonia, run by Ann & Robert H Lurie Children's Hospital of Chicago at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Todd Florin, MD, MSCE (312-227-6675, taflorin@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Improvement (time frame: From enrollment to day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.