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

NCT06364514 | Recruiting DMC

• 1 other identifier: IRB-P00047313
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Median days of antibiotics received for patients in the intervention group as well as from historical control group

  30 days

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Clinical Stability Assessment OTHER

Base total days of antibiotics on clinical stability vs utilizing predetermined total days of antibiotics

Intervention Group

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Kathleen Snow, MD

CONTACT

6178238926; kathleen.snow@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Pediatrics

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 15, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)