Recruiting

Short-course Therapy

Sponsor:

Jeffrey

Code:

NCT06125340

Conditions

Community-acquired Pneumonia

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Placebo

Amoxicillin

Study Details

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 ID

NCT06125340

Start date

Apr 17, 2024

Status verified date

Apr, 2024

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

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.

Primary outcome measure

  • Consent success [ Time Frame: Day 0 ]
  • Open-label antibiotic use [ Time Frame: before Day 30 ]
  • Losses to followup [ Time Frame: before Day 30 ]

Central Contacts and Locations

Central contacts

Jeffrey Pernica, MD

9055212100pernica@mcmaster.ca

Shamini Selvakumar, MD

9055212100selvaks@mcmaster.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Jeffrey Pernica, MD

9055212100pernica@mcmaster.ac

More Information

Sponsor

Jeffrey

Last update posted

Dec 12, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jeffrey on 2024-12-12.