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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia
• Intervention / Treatment: Other: Clinical Stability Assessment

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen Snow, MD; Phone Number: 6178238926; Email: kathleen.snow@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Group; Patients will be started on antibiotics for treatment of pneumonia per usual care by their medical provider team. The research team will monitor enrolled patients daily for markers of their clinical status (caregiver assessment of respiratory status, supplemental oxygen/respiratory support, presence of fever). Once the patient has been "clinically stable" x48 hours, antibiotics will be discontinued.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible patients who consent to participate in the intervention	Caregiver and medical provider acceptability	48 hours
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median days of antibiotics received for patients in the intervention group as well as from historical control group	Pneumonia antibiotic duration	30 days

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: IRB-P00047313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No