Acute respiratory infection or infection of unkwon fcous
Conditions
Interventions
Group 1: Patients in the emergency department with a suspected acute respiratory infection or an unclear focus of infection receive a MeMedBV test in parallel with routine treatment after inclusion in
Sponsors
Charite - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients presenting to or being admitted to the emergency department with a clinical suspicion of an acute respiratory infection or an infection of unclear origin. Participant is willing and able to give informed consent for participation in the trial. Male or Female, aged 18 years or above
Exclusion criteria
Exclusion criteria: =48 hours of oral antibiotic treatment =12 hours of intravenous\intramuscular antibiotic treatment Human Immunodeficiency Viruses (HIV) Hepatitis B Virus (HBV) infection (self-declared or known from medical records) 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: Active malignancy treated within last 6 months Current treatment with immune-suppressive or immune-modulating therapies, including without limitations: Administration of P.O.\IV\IM high dose steroids>1mg/kg/day prednisone (or equivalent) at somepoint in the past 10 days or daily continuous use ofsteroids > 0.25 mg/kg/day in the past 7 days. Monoclonal antibodies, anti-TNF agents. Intravenous immunoglobulin (IVIG). Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate. G/GM-CSF Interferons Post solid organ/bone marrow transplant patients Asplenia,sickle cell disease Cystic Fibrosis Pregnancy Patients previously enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity of MeMedBV (threshold = 35) as a screening tool for true-positive blood cultures is >85%. | — |
Secondary
| Measure | Time frame |
|---|---|
| A high MeMedBV (>65) has a high positive predictive value (>90%) for bacterial infection. The diagnostic accuracy of MeMedBV as a continuous value, quantified as the area under the ROC curve (AUROC), is at least equivalent to the available standard parameters for detecting bacterial infection. The diagnostic accuracy of MeMedBV as a continuous value, quantified as the area under the ROC curve (AUROC), is at least equivalent to the available standard parameters for detecting and predicting sepsis. The diagnostic accuracy of MeMedBV as a continuous value, quantified as the area under the ROC curve (AUROC), is at least equivalent to the available standard parameters for predicting 30-day mortality. | — |
Countries
Germany
Contacts
Public ContactWolfgang Bauer
Charite - Universitätsmedizin Berlin
Outcome results
None listed