Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of Short-course Antibiotic Therapy

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

Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adults hospitalized with CAP - but there is very little evidence in children. We intend to do a pilot RCT of short-course (3-5 days) vs standard-duration (8-10 days) antibiotic therapy for children hospitalized for CAP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 18
Healthy Volunteers: f
View:

• \- children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:

‣ documented tachypnoea (\>60 bpm for age \<1 y, \>50 bpm for 1-2 y, \>40 bpm for 2-4 y, and \>30 bpm for \>4 y);

⁃ cough on exam or by history;

⁃ increased work of breathing on exam; or

⁃ auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.

Locations
Other Locations
Canada
McMaster Children's Hospital
RECRUITING
Hamilton
Contact Information
Primary
Jeffrey Pernica, MD
pernica@mcmaster.ca
9055212100
Backup
Shamini Selvakumar, MD
selvaks@mcmaster.ca
9055212100
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 75
Treatments
Experimental: Short-course treatment
5 days of placebo (after participants already received 3-5 days of antibiotics)
Active_comparator: Standard-duration treatment
5 days of amoxicillin (after participants already received 3-5 days of antibiotics)
Related Therapeutic Areas
Sponsors
Leads: Jeffrey

This content was sourced from clinicaltrials.gov