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

NCT06125340 | Recruiting Phase 4

• 1 other identifier: HHS-CB 2023-Pernica-2
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (3)

• Consent success

  The proportion of potentially eligible participants who consent

  Day 0

• Open-label antibiotic use

  The proportion of participants who receive open-label (non-study) antibiotics

  before Day 30

• Losses to followup

  The proportion of participants lost to follow-up

  before Day 30

Secondary Outcomes (7)

• Proportion of participants with late clinical response

  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

Study Arms (2)

Short-course treatment

EXPERIMENTAL

5 days of placebo (after participants already received 3-5 days of antibiotics)

Drug: Placebo

Standard-duration treatment

ACTIVE COMPARATOR

5 days of amoxicillin (after participants already received 3-5 days of antibiotics)

Drug: Amoxicillin

Interventions

Placebo DRUG

5 days of placebo to be given after 3-5 days of antibiotics

Short-course treatment

Amoxicillin DRUG

Standard-dose amoxicillin (approved by Health Canada) to be given x 5 days.

Standard-duration treatment

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeffrey: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jeffrey Pernica, MD

CONTACT

9055212100; pernica@mcmaster.ca

Shamini Selvakumar, MD

CONTACT

9055212100; selvaks@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants in all arms will receive 5 days of study medications.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: April 17, 2024
• Primary Completion: November 30, 2025
• Study Completion: January 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-04

Locations

CA (1)