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

NCT ID: NCT06125340

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2026-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Short-course treatment

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Standard-duration treatment

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

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

Amoxicillin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jeffrey

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jeffrey Pernica, MD

Role: CONTACT

Phone: 9055212100

Email: pernica@mcmaster.ca

Shamini Selvakumar, MD

Role: CONTACT

Phone: 9055212100

Email: selvaks@mcmaster.ca

Facility Contacts

Jeffrey Pernica, MD

Role: primary

Other Identifiers

HHS-CB 2023-Pernica-2

Identifier Type: -

Identifier Source: org_study_id