Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy

Community-acquired Pneumonia Clinical Trial

— PRESTO-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125340
• Other study ID #: HHS-CB 2023-Pernica-2
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Hamilton Health Sciences Corporation
• Contact: Jeffrey Pernica, MD
• Phone: 9055212100
• Email: pernica[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 1, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Placebo
5 days of placebo to be given after 3-5 days of antibiotics
• Amoxicillin
Standard-dose amoxicillin (approved by Health Canada) to be given x 5 days.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey Pernica

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consent success	The proportion of potentially eligible participants who consent	Day 0
Primary	Open-label antibiotic use	The proportion of participants who receive open-label (non-study) antibiotics	before Day 30
Primary	Losses to followup	The proportion of participants lost to follow-up	before Day 30
Secondary	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
Secondary	Proportion of participants with repeat hospitalization for CAP		before Day 30
Secondary	Proportion of participants with drug-related AEs (any severity)		before Day 30
Secondary	Proportion of participants with serious drug AEs		before Day 30
Secondary	Proportion of participants with unscheduled ED or urgent care visits		before Day 30
Secondary	Proportion of participants with unscheduled primary care visits		before Day 30
Secondary	Proportion of participants who develop complicated pneumonia	Complicated defined by effusion, empyaema, necrotizing pneumonia	before Day 30