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Recruiting NCT06364514

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

No phase Interventional Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical Stability Assessment.
Who it may be relevant to
Registry conditions: Pneumonia. Basic parameters: 2 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of eligible patients who consent to participate in the intervention [Time frame: 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 [Time frame: 1 week]
Secondary outcome measures (1)
  • Median days of antibiotics received for patients in the intervention group as well as from historical control group [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

Identifiers

NCT: NCT06364514 · IRB-P00047313

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗