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| ID | Type | Description | Link |
|---|---|---|---|
| BPS-2023C3-35456 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Antibiotic Prescribing Group Instructions | Other | Children randomized to the immediate antibiotic prescribing group will receive an antibiotic prescription with instructions to fill and administer the antibiotics. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | From enrollment to day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Exposure | Antibiotic exposure, defined as the number of days antibiotics were consumed through day 7 and day 14. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic-associated Adverse Events | Rash, diarrhea, diaper dermatitis, oral thrush, vomiting, anaphylaxis | From enrollment to day 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Todd Florin, MD, MSCE | Contact | 312-227-6675 | taflorin@luriechildrens.org | |
| Julia Szymczak, PhD | Contact | julia.szymczak@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Todd Florin, MD, MSCE | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Julia Szymczak, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30329 | United States |
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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| Safety Net Antibiotic Prescribing (SNAP) Group Instructions | Other | 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. |
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| 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. | 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 | From enrollment to day 14 |
| Return to Care | Parent-reported return to medical care after index visit and reason for return | From enrollment to day 14 |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Primary Children's Hospital | Recruiting | Salt Lake City | Utah | 84108 | United States |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
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