Last updated: December 8, 2024
Sponsor: Jeffrey
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pneumonia
Pneumonia (Pediatric)
Treatment
MeMed BV + Usual Care
Usual Care Alone
Clinical Study ID
NCT06114888
HHS-CB 2023-Pernica-1
Ages 6-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') asper 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:
documented tachypnoea (>60 bpm for age <1 y, >50 bpm for 1-2 y, >40 bpm for 2-4y, and >30 bpm for >4 y);
cough on exam or by history;
increased work of breathing on exam; or
auscultatory findings (eg. focal crackles, bronchial breathing) consistent withCAP.
Exclusion
Exclusion Criteria:
- Children will be excluded from if they have received >48h of intravenous antibiotics (eg. if transferred from another healthcare facility) or if they have a lobarconsolidation that occupies the majority of a lobe on imaging, a pleural effusionthat occupies more than ¼ of a lung field, or a positive blood culture for abacterial pathogen (not a contaminant). Examples of CAP pathogens include S.pneumoniae, S. pyogenes (group A streptococcus), S. aureus, S. anginosus. Examplesof contaminants that would be ignored include the coagulase-negative staphylococciand Bacillus spp. Children will also be excluded if they have any of the following:chronic lung disease, congenital heart disease (requiring treatment or with exerciserestrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), aseparate episode of pneumonia previously diagnosed within the past 2 weeks, or lungabscess diagnosed within the past six months. Children will not be eligible toparticipate more than once.
Study Design
Total Participants: 75
Treatment Group(s): 2
Primary Treatment: MeMed BV + Usual Care
Phase:
Study Start date:
April 17, 2024
Estimated Completion Date:
January 01, 2026
Connect with a study center
McMaster Children's Hospital
Hamilton, Ontario L8S 4K1
CanadaActive - Recruiting
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