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Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
N/A
Recruiting
Research Sponsored by Beckman Coulter, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up less or equal to seven days
Awards & highlights
No Placebo-Only Group
Summary
The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (\>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance.
Eligible Conditions
- Bacterial Infection
- Viral Infections
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ less or equal to seven days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~less or equal to seven days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Specimen Collection
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Adult and PediatricsExperimental Treatment1 Intervention
A minimum of 244 serum samples will be collected at a minimum of two (2) US locations from enrolled pediatric and adult patients presenting signs and symptoms suggestive of acute bacterial or viral infection. The number of patients enrolled is based on total volume required to run analytical comparison studies under a future testing protocol.
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Who is running the clinical trial?
MeMed Diagnostics Ltd.Industry Sponsor
16 Previous Clinical Trials
14,272 Total Patients Enrolled
Beckman Coulter, Inc.Lead Sponsor
37 Previous Clinical Trials
443,095 Total Patients Enrolled
David HaanStudy DirectorBeckman Coulter, Inc.