Short-course antibiotic therapy for children with pneumonia

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

This study is testing if a shorter course of antibiotics for 3-5 days can effectively treat children with pneumonia compared to the usual 8-10 days of treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 6 Months to 18 Years
• Sex: All
• Sponsor: McMaster University (Academic / other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT06125340 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of short-course antibiotic therapy (3-5 days) compared to standard-duration therapy (8-10 days) for children hospitalized with community-acquired pneumonia (CAP). The study will involve a pilot randomized controlled trial to assess outcomes in children who meet specific clinical criteria for severe CAP. The primary focus is to gather evidence on the safety and efficacy of shorter antibiotic treatment durations in pediatric patients, an area that currently lacks robust data. Participants will receive either amoxicillin or a placebo as part of their treatment regimen.

Who should consider this trial

Good fit: Ideal candidates for this study are children hospitalized with severe community-acquired pneumonia who exhibit specific clinical signs such as fever and abnormal chest imaging.

Not a fit: Patients who have already received more than three days of effective antibiotic treatment prior to hospitalization may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and shorter treatment protocols for children with pneumonia, reducing hospital stays and antibiotic exposure.

How similar studies have performed: While there is substantial evidence supporting short-course therapy in adults, this approach in children is less established, making this study a novel investigation.

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.

Where this trial is running

Hamilton, Ontario

• McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Jeffrey Pernica, MD

Conditions Community-acquired Pneumonia