Clinical Stability Assessment for Pneumonia in Children

N/A

Recruiting

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 2-25 years old

Admitted to the Complex Care Service at Boston Children's Hospital with a provider diagnosis of pneumonia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if doctors can safely give less antibiotics to children with complex medical conditions who have pneumonia by adjusting the duration of antibiotics based on how stable the child is clinically. "This trial investigates

Who is the study for?

The PICNIC Study is for children and young adults aged 2-25 with complex medical conditions who are diagnosed with pneumonia. They must have started antibiotics and be admitted to the Complex Care Service at Boston Children's Hospital.

What is being tested?

The study tests if doctors can safely shorten antibiotic use in these patients by deciding how long to treat based on when the patient starts getting better, rather than a set number of days.

What are the potential side effects?

Since this trial focuses on duration of treatment rather than a new medication, side effects may not differ from standard antibiotic use but could include digestive issues, allergic reactions, or increased resistance to antibiotics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 and 25 years old.

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I am admitted to Boston Children's Hospital for pneumonia.

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My doctor has started me on antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of eligible patients who consent to participate in the intervention

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met