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NCT06364514 Clinical Trial

PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity

Pneumonia Clinical Trial

Official title:
PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06364514
Other study ID # IRB-P00047313
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date October 1, 2025

Study information
Verified date April 2024
Source Boston Children's Hospital
Contact Kathleen Snow, MD
Phone 6178238926
Email kathleen.snow@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date October 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years to 25 Years
Eligibility Inclusion Criteria: - Admitted to the Complex Care Service at Boston Children's Hospital with a provider diagnosis of pneumonia - Started on antibiotics by the provider team - Ages 2-25 years old Exclusion Criteria: - Patients initially admitted to the intermediate care unit or ICU due to increased respiratory support needs

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Clinical Stability Assessment
Base total days of antibiotics on clinical stability vs utilizing predetermined total days of antibiotics

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of eligible patients who consent to participate in the intervention Caregiver and medical provider acceptability 48 hours
Primary Rate of persistent and worsening respiratory symptoms measured by patient's clinical status; the rate of emergency department revisit or hospital readmission within 1 week of antibiotic discontinuation Patient Safety Outcomes 1 week
Secondary Median days of antibiotics received for patients in the intervention group as well as from historical control group Pneumonia antibiotic duration 30 days
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