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

Not Applicable

Recruiting

• Conditions: Pneumonia
• Interventions: Other: Clinical Stability Assessment

• Registration Number: NCT06364514
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-15
• Study Start: 2024-08-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• Patients initially admitted to the intermediate care unit or ICU due to increased respiratory support needs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Clinical Stability Assessment	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.

Primary Outcome Measures

Name	Time	Method
Proportion of eligible patients who consent to participate in the intervention	48 hours	Caregiver and medical provider acceptability
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	1 week	Patient Safety Outcomes

Secondary Outcome Measures

Name	Time	Method
Median days of antibiotics received for patients in the intervention group as well as from historical control group	30 days	Pneumonia antibiotic duration

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States