drugset / Trial / NCT06494072

Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP

NCT06494072

Phase 4 Recruiting 236 enrolled Medical College of Wisconsin
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-08-22
Primary completion
2028-05
Completion
2028-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified Oral
Subject Ampicillin Unknown Intravenous
Subject Ampicillin/Sulbactam Unknown Intravenous
Subject CEFPROZIL ANHYDROUS, (E)- Small molecule Oral
Subject Ceftriaxone Other / unclassified Intravenous
Subject Clindamycin Unknown Intravenous
Subject Levofloxacin Small molecule Intravenous

Indications

No indication recorded.