Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP (NCT06494072) | Clinical Trial Compass
RecruitingPhase 4
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
United States236 participantsStarted 2024-08-22
Plain-language 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 antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia.
The main questions it aims to answer are:
* Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?
* Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia?
Participants will
* be randomly assigned to either receive 5 total days or a total duration decided by the treating physician
* receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics
Researchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.
Who can participate
Age range3 Months – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✕. 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
✕
What they're measuring
1
Treatment failure rate
Timeframe: 14 days from the first dose antibiotics