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RECRUITING
NCT06494072
PHASE4

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

Sponsor: Medical College of Wisconsin

View on ClinicalTrials.gov

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.

Official title: Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.

Key Details

Gender

All

Age Range

3 Months - 18 Years

Study Type

INTERVENTIONAL

Enrollment

236

Start Date

2024-08-22

Completion Date

2028-05

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DRUG

Ampicillin for Injection

Ampicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.

DRUG

Ceftriaxone for Injection

Ceftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.

DRUG

Amoxicillin

Amoxicillin is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.

DRUG

Ampicillin / Sulbactam Injection

Ampicillin/Sulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.

DRUG

Amoxicillin-clavulanate

Amoxicillin-clavulanate is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.

DRUG

Clindamycin

Clindamycin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.

DRUG

Cefprozil

Cefprozil is an oral antibiotic sometimes used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.

DRUG

Levofloxacin

Levofloxacin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.

Locations (1)

Childrens Wisconsin

Milwaukee, Wisconsin, United States