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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

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

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

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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