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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Wisconsin
Childrens Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Michelle Mitchell, MD
mimitchell@mcw.edu
414-337-7070
Backup
Khaled AL zubaidi, MD
kalzubaidi@mcw.edu
414-337-7070
Time Frame
Start Date: 2024-08-22
Estimated Completion Date: 2027-05
Participants
Target number of participants: 236
Treatments
Experimental: Short course antibiotic duration
The participants in this group will receive a total antibiotic course of 5 days including the number of days received during their hospital admission and following hospital admission combined.
Active_comparator: Standard of care antibiotic duration
Participants will receive the standard-of-care antibiotic course in this group. That is, the duration of antibiotics will be decided by the primary treating physician in this group. The antibiotic course will include the number of days received during the participant's hospital admission and following hospital admission combined.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov