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

NCT ID: NCT06364514

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2026-10-01

Brief Summary

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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

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Conditions

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Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical Stability Assessment

Intervention Type OTHER

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

Interventions

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Clinical Stability Assessment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Snow

Instructor, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen Snow, MD

Role: CONTACT

Phone: 6178238926

Email: [email protected]

Facility Contacts

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Kathleen D Snow, MD, MPH

Role: primary

Other Identifiers

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IRB-P00047313

Identifier Type: -

Identifier Source: org_study_id