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Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts

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Conditions

Infection, BacterialInfection Viral

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts

Quick Facts

Study Start:2024-06-12
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06379061

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:90 Days to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Over 90 days of age.
  2. * Clinical suspicion of acute bacterial or viral infection.
  3. * Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days.
  4. * Current disease duration ≤ 7 days.
  1. * Previously enrolled
  2. * Insufficient sample volumes obtained
  3. * For the adult and pediatric populations, \< 1.2 mL serum volume
  4. * Sample handling errors
  5. * Another unrelated episode of febrile infection within the past 2 weeks
  6. * Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
  7. * ≥48 hours of oral antibiotic treatment
  8. * ≥12 hours of intravenous\\intramuscular antibiotic treatment
  9. * Human Immunodeficiency Viruses (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)
  10. * A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
  11. * Active inflammatory disease (e.g., Inflammatory Bowel Disease \[IBD\], Systemic Lupus Erythematosus \[SLE\], Juvenile Idiopathic Arthritis \[JIA\], Rheumatoid Arthritis \[RA\], Kawasaki, other vasculitis)
  12. * Major trauma and\\or burns in the last 7 days.
  13. * Major surgery in the last 7 days
  14. * Congenital immune deficiency (CID)
  15. * Acquired immune deficiency\\modulation state including
  16. 1. Active malignancy treated within last 6 months
  17. 2. Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
  18. * Indwelling central venous catheter
  19. * Cystic Fibrosis
  20. * Pregnancy - self-reported or medically known
  21. * Other severe illnesses that affect life expectancy and quality of life such as:
  22. 1. Severe psychomotor retardation
  23. 2. Congenital metabolic disorder
  24. 3. End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)

Contacts and Locations

Principal Investigator

David Haan
STUDY_DIRECTOR
Beckman Coulter, Inc.

Study Locations (Sites)

Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Massachusetts General Brigham
Boston, Massachusetts, 02114
United States
Wayne State University
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Beckman Coulter, Inc.

  • David Haan, STUDY_DIRECTOR, Beckman Coulter, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-12
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2024-06-12
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Infection, Bacterial
  • Infection Viral