Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy (PRESTO-2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Placebo; Drug: Amoxicillin

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeffrey Pernica, MD; Phone Number: 77577 9055212100; Email: pernica@mcmaster.ca
• Study Contact Backup: Name: Shamini Selvakumar, MD; Phone Number: 9055212100; Email: selvaks@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Recruiting
      • McMaster Children's Hospital
      • Contact: Jeffrey Pernica, MD; Phone Number: 77577 9055212100; Email: pernica@mcmaster.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - 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:

  1. 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);
  2. cough on exam or by history;
  3. increased work of breathing on exam; or
  4. auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.

Exclusion Criteria:

• Children will be excluded if: antibiotics have been discontinued; they received >3 days of effective antibiotic treatment (excluding macrolide treatment) prior to hospitalization; there is supplemental oxygen use or fever within the past 24 h; more than 5 days elapsed since admission; the attending clinical team does not wish to use oral amoxicillin for treatment (because of allergy or any other reason); or the child is taking coumadin-based anticoagulants or tetracycline-type antibiotics (because of potential interactions with amoxicillin). Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short-course treatment; 5 days of placebo (after participants already received 3-5 days of antibiotics)	Drug: Placebo; 5 days of placebo to be given after 3-5 days of antibiotics
Active Comparator: Standard-duration treatment; 5 days of amoxicillin (after participants already received 3-5 days of antibiotics)	Drug: Amoxicillin; Standard-dose amoxicillin (approved by Health Canada) to be given x 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consent success	The proportion of potentially eligible participants who consent	Day 0
Losses to followup	The proportion of participants lost to follow-up	before Day 30
Open-label antibiotic use	The proportion of participants who receive open-label (non-study) antibiotics	before Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with late clinical response	LCR is defined as: i) clinical improvement in fever, work of breathing, oral intake, and activity level, AND ii) lack of receipt of additional antimicrobials	Day 15
Proportion of participants with repeat hospitalization for CAP		before Day 30
Proportion of participants with drug-related AEs (any severity)		before Day 30
Proportion of participants with serious drug AEs		before Day 30
Proportion of participants with unscheduled ED or urgent care visits		before Day 30
Proportion of participants with unscheduled primary care visits		before Day 30
Proportion of participants who develop complicated pneumonia	Complicated defined by effusion, empyaema, necrotizing pneumonia	before Day 30

Collaborators and Investigators

• Sponsor: Jeffrey

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 4, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Bacterial Agents; Anti-Infective Agents; Amoxicillin
• Other Study ID Numbers: HHS-CB 2023-Pernica-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No