Recruiting

Antibiotic Treatment

Sponsor:

Jeffrey Pernica

Code:

NCT07099976

Conditions

Community-Acquired Pneumonia (CAP)

Pneumonia

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

The novel care pathway intervention

Usual Care Alone

Study Details

Brief summary:

In North America, up to 5% of preschoolers develop community-acquired pneumonia (CAP) every year. Pneumonia is the second-leading reason for paediatric hospitalization in both Canada and the US; approximately 20% of children hospitalized with CAP may need intensive care, which can result in significant morbidity. Given this burden of disease, it is critical that CAP is managed appropriately. Specific therapy for CAP is dependent on microbiologic aetiology, as bacterial disease will improve with antibiotic treatment.

Conditions

Community-Acquired Pneumonia (CAP)

Pneumonia

Study ID

NCT07099976

Start date

Apr 15, 2026

Status verified date

Apr, 2026

Completion date

May 15, 2030

Anticipated

Primary completion date

Apr 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

Children aged 6 month to 18 years presenting to the Emergency Department who are diagnosed with CAP and are well enough to be discharged home (i.e. 'non-severe' CAP) will be eligible. They must have a fever (on exam or by history) and at least one of:

  • Tachypnoea measured at triage (>60 bpm for age <1, >50 for 1-2 years of age, >40bpm for 2-4 years of age, and >30bpm for >4 years of age)
  • Cough on exam or by history
  • Increased work of breathing on exam
  • Auscultatory finding (focal crackles, bronchial breathing, etc.) consistent with CAP

Exclusion Criteria:

Children will be excluded if they have any of the following

  • Cystic Fibrosis
  • Anatomic Lung Disease
  • Bronchiectasis
  • Chronic Lung Disease requiring home oxygen or home ventilation
  • Congenital heart Disease (requiring specific medical treatment or with exercise restrictions),
  • History of repeated aspiration/velopharyngeal incompetence
  • Malignancy
  • Immunodeficiency (primary, acquired or iatrogenic)
  • Pneumonia previously (clinically) diagnosed within the past month (that was presumed to have resolved prior to the episode prompting the current visit to the ED)
  • Lung abscess within the past 6 months
  • Children who present with ongoing fever after 4 days of amoxicillin, cefprozil, cefuroxime, levofloxacin, moxifloxacin or doxycycline are not eligible; as this duration of therapy with these drugs would normally be sufficient to treat bacterial CAP, a different approach would be required (ie. the care pathway as written might not be appropriate).
  • Children will not be eligible to participate more than once

Study Design

Enrollment

698 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: The novel care pathway intervention

The novel care pathway intervention will incorporate multiple factors to determine risk of bacterial CAP. At recruitment, POC CRP testing, and bioMérieux Spotfire testing of nasopharyngeal swabs (NPS) will identify those who are at appreciable risk and will receive a prescription for antibiotic treatment on day 0. Please refer to the Specimen Collection and Processing manual for more specific information on the collection process. Appreciable-risk participants will be referred back to the clinical team to be given amoxicillin, the current standard of care in Canada (those with penicillin allergy will presumably receive an appropriate substitution as per local guidelines). Low-risk participants will be discharged home without antibiotics.

active comparator: Control Group

Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management

Interventions

The novel care pathway intervention

The pathway uses already-ascertained data, bioMérieux Spotfire testing, and POC CRP testing to stratify patients into risk categories. The first step in the pathway will be POC CRP testing; children with CRP > 60 mg/L will be deemed 'appreciable risk', whereas those with CRP < 20 mg/L will be deemed 'low risk'. The CRP cut-offs of 20mg/L (more sensitive) and 60mg/L (more specific) were selected after reviewing the literature, with particular emphasis on meta-analyses; other large recent studies have also used 60mg/L as an upper cut-off for bacterial infection. Participants with CRP between 20-60mg/L will be categorized further to identify children either more likely to have bacterial pneumonia or more intolerant of misclassification. 'If they have O2 saturation <95% AND tachypnoea as per age-specific norms, they will be 'appreciable risk' (>60 bpm for age <1 y, >50 bpm for 1-2 y, >40 bpm for 2-4 y, and >30 bpm for >4 y).

Usual Care Alone

Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management.

Primary outcome measure

  • Antibiotic use for CAP or respiratory tract infection before day 7 post-enrolment [ Time Frame: From enrollment to 7 days post enrollment ]
  • Early clinical response (ECR, clinical improvement in symptoms and lack of requirement for additional antibacterials as measured at day 4). [ Time Frame: From enrollment to day 4 ]

Central Contacts and Locations

Central contacts

Jeffrey Pernica, MD

905-521-2100pernica@mcmaster.ca

Locations

Alberta Children's hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Mohamed Eltorki, MD

403-955-7211mmeltork@ucalgary.ca

Principal Investigator:

Mohamed Eltorki, MD

Children's Hospital of Eastern Ontario (CHEO)

Recruiting

Ottawa, Ontario, Canada, K1H 8M8

Contacts

Stuart Harman, MD

613-737-7600sharman@cheo.on.ca

Principal Investigator:

Stuart Harman, MD

More Information

Sponsor

Jeffrey Pernica

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Pneumonia
  • Antibiotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jeffrey Pernica on 2026-04-29.