Recruiting

Antibiotic Courses

Sponsor:

Boston Children's Hospital

Code:

NCT06364514

Conditions

Pneumonia

Eligibility Criteria

Sex: All

Age: 2 - 25

Healthy Volunteers: Not accepted

Interventions

Clinical Stability Assessment

Study Details

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

Study ID

NCT06364514

Start date

Aug 20, 2024

Status verified date

Nov, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Clinical Stability Assessment

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kathleen Snow, MD

6178238926kathleen.snow@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kathleen D Snow, MD, MPH

kathleen.snow@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-11-12.