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Adult and Pediatrics for Bacterial Infection

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

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 weeks
Treatment ~ Varies
Follow Up ~less or equal to seven days
This trial's timeline: 3 weeks for screening, Varies for treatment, and less or equal to seven days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Specimen Collection

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.

Find a Location

Who is running the clinical trial?

MeMed Diagnostics Ltd.Industry Sponsor
15 Previous Clinical Trials
12,272 Total Patients Enrolled
Beckman Coulter, Inc.Lead Sponsor
34 Previous Clinical Trials
440,251 Total Patients Enrolled
David HaanStudy DirectorBeckman Coulter, Inc.
~200 spots leftby Dec 2024
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