Clinical trial NCT06125340: Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy
Official title: Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of Short-course Antibiotic Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Community-acquired Pneumonia
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Consent success
timeFrame: Day 0
measure: Open-label antibiotic use
timeFrame: before Day 30
measure: Losses to followup
timeFrame: before Day 30
Secondary outcomes:
measure: Proportion of participants with late clinical response
timeFrame: Day 15
measure: Proportion of participants with repeat hospitalization for CAP
timeFrame: before Day 30
measure: Proportion of participants with drug-related AEs (any severity)
timeFrame: before Day 30
measure: Proportion of participants with serious drug AEs
timeFrame: before Day 30
measure: Proportion of participants with unscheduled ED or urgent care visits
timeFrame: before Day 30
measure: Proportion of participants with unscheduled primary care visits
timeFrame: before Day 30
measure: Proportion of participants who develop complicated pneumonia
timeFrame: before Day 30
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
References: