ImmunoXpert
Diagnostic TestHost based immune response test distinguishing viral versus bacterial infection
NCT Number: NCT03075111
This is a retrospective external field study of a novel in vitro diagnostic (IVD) assay (ImmunoXpert™).
The study will involve reviewing the medical charts of about 4500 pediatric patients that were tested using ImmunoXpert™ as part of the routine workup for acute febrile illness.
ImmunoXpert™ uses a computer algorithm to combine immunoassay measurements of three host immune proteins (TRAIL, IP-10, and CRP) present in human blood. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection.
Statistical analysis will be performed to compare the diagnostic accuracy of ImmunoXpert™ with that of current practice lab testing e.g., WBC, CRP, and PCT (whichever were taken as part of routine care) and clinical suspicion at time of requisition.
Looking for future studies?
Notify Me3 month–18 year
All sexes
Observational
Hillel Yaffe Medical center, Hadera, Israel
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The febrile illness should also fulfill the following criteria:
The non-infectious disease control group will include:
Exclusion criteria
Host based immune response test distinguishing viral versus bacterial infection
Time frame: 0-7 days after the initiation of symptoms
Time frame: 0-7 days after the initiation of symptoms
MeMed Diagnostics Ltd.
Industry
Field Study of Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07086547
Anxiety Disorders, Body Temperature Changes
Kayseri, Talas, Turkey (Türkiye)
View Trial DetailsNCT06855576
Body Temperature Changes, Fever
Erfurt, Thuringia, Germany
View Trial DetailsNCT01175005
Body Temperature Changes, Fever
View Trial DetailsNCT06637878
Body Temperature Changes, Fever
Miami, Florida, United States
View Trial Details