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Biomarker Assay
MeMed BV for Community-acquired Pneumonia (PRESTO-1 Trial)
N/A
Recruiting
Research Sponsored by Jeffrey Pernica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have at least one of the following: documented tachypnoea, cough on exam or by history, increased work of breathing on exam, or auscultatory findings consistent with CAP
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before discharge
Awards & highlights
PRESTO-1 Trial Summary
This trial aims to see if a new test called MeMed BV can help doctors prescribe antibiotics more accurately to children with pneumonia. Many children are hospitalized with pneumonia, but not all cases require antibiotics. The
Who is the study for?
This trial is for children hospitalized with community-acquired pneumonia who show signs like fast breathing, coughing, and difficulty in breathing or specific sounds in their lungs. It's not suitable for those who don't meet the breathing rate criteria or other specified conditions.Check my eligibility
What is being tested?
The study tests if using MeMed BV (a test that helps determine if an infection is viral) along with usual care can improve antibiotic use compared to just usual care. The goal is to see if this approach reduces unnecessary antibiotic treatment.See study design
What are the potential side effects?
Since MeMed BV is a diagnostic test, it has minimal side effects related to the blood draw required. Usual care side effects depend on treatments given but may include typical medication reactions.
PRESTO-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms like fast breathing, coughing, or signs of lung infection.
PRESTO-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Consent success
Losses to followup
MeMed BV test result delayed adherence
+3 moreSecondary outcome measures
Acceptability of care plan to caregiver
Days of antibiotics given specifically for CAP after hospital discharge and before day 30
Days of antibiotics given specifically for CAP before hospital discharge
+9 morePRESTO-1 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MeMed BVExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention
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Who is running the clinical trial?
Jeffrey PernicaLead Sponsor
2 Previous Clinical Trials
151 Total Patients Enrolled
1 Trials studying Community-acquired Pneumonia
75 Patients Enrolled for Community-acquired Pneumonia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals older than 85 years eligible to participate in this clinical trial?
"Potential candidates should be younger than 18 years old but older than 6 months to qualify for enrollment in this clinical trial."
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