Status:
RECRUITING
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Community Acquired Pneumonia in Children
Eligibility:
All Genders
3-18 years
Phase:
PHASE4
Brief Summary
The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antib...
Detailed Description
This is an open label, randomized, non-inferiority clinical trial to determine if a 5-day antibiotic course works as well compared to a standard antibiotic course (usually 7-10 days of antibiotics) in...
Eligibility Criteria
Inclusion
- Inclusion Criteria (ALL of the following must be met):
- Children aged 3 months to \<18 years old
- Hospitalized in either the acute care or the pediatric intensive care units
- Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)
- Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)
- Achieved clinical stability within 72 hours from the first antibiotic dose (clinical stability includes being off supplemental oxygen/ventilatory support and temperature remaining \< 38 Celsius).
- Exclusion Criteria (presence of ANY of the following will exclude a potential participant):
- Hemodynamic instability at any point during hospitalization that required inotropic support
- Requirement of respiratory support \> 72 hours
- Presence of a parapneumonic effusion \>10 mm on decubitus x-ray or greater than ¼ of hemithorax opacified on chest imaging
- Need for chest tube placement
- Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days
- Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid)
- Antibiotic course started \>72 hours after admission
- Antibiotics used for \> 24 hours within the 2 weeks prior to admission
- Chronic respiratory illness other than asthma or reactive airway disease
- Immunocompromised patient (primary or secondary)
- Primary physician refusal
- Parent refusal
- Non-English speakers
- Pregnant or lactating female
- Participant will become ≥ 18 years old at or before the time of day 14 follow up
- Inability to adhere to follow up
Exclusion
Key Trial Info
Start Date :
August 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT06494072
Start Date
August 22 2024
End Date
May 1 2027
Last Update
November 20 2024
Active Locations (1)
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1
Childrens Wisconsin
Milwaukee, Wisconsin, United States, 53226