Infection, Bacterial Clinical Trial
Official title:
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
NCT number | NCT06379061 |
Other study ID # | MM-01-24 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 12, 2024 |
Est. completion date | March 31, 2025 |
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | March 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 90 Days to 89 Years |
Eligibility | Inclusion Criteria: - Over 90 days of age. - Clinical suspicion of acute bacterial or viral infection. - 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. - Current disease duration = 7 days. Exclusion Criteria: - Previously enrolled - Insufficient sample volumes obtained - For the adult and pediatric populations, < 1.2 mL serum volume - Sample handling errors - Another unrelated episode of febrile infection within the past 2 weeks - Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis. - =48 hours of oral antibiotic treatment - =12 hours of intravenous\intramuscular antibiotic treatment - Human Immunodeficiency Viruses (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records) - A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen - Active inflammatory disease (e.g., Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE], Juvenile Idiopathic Arthritis [JIA], Rheumatoid Arthritis [RA], Kawasaki, other vasculitis) - Major trauma and\or burns in the last 7 days. - Major surgery in the last 7 days - Congenital immune deficiency (CID) - Acquired immune deficiency\modulation state including 1. Active malignancy treated within last 6 months 2. Current treatment with immune-suppressive or immune-modulating therapies, including without limitations: i. Administration of P.O.\IV\IM high dose steroids >1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids > 0.25 mg/kg/day in the past 7 days ii. Monoclonal antibodies, anti-TNF agents iii. Intravenous immunoglobulin (IVIG) iv. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate v. G/GM-CSF Interferons c. Post solid organ/bone marrow transplant patients d. Asplenia, sickle cell disease - Indwelling central venous catheter - Cystic Fibrosis - Pregnancy - self-reported or medically known - Other severe illnesses that affect life expectancy and quality of life such as: 1. Severe psychomotor retardation 2. Congenital metabolic disorder 3. End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4) |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University School of Medicine | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Beckman Coulter, Inc. | MeMed Diagnostics Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Specimen Collection | Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection | Less or equal to seven days |
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