An observational study in Acute Febrile Illnesses, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 3 sites in 3 countries. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
This project aims to evaluate the performance characteristics of rapid tests to differentiate bacterial from non-bacterial infection in febrile adults and children presenting at OPDs (outpatient departments) i.e.("fever triage assays") in three LMICs. The evaluation will include a different commercial biomarker combinations as well as individual biomarkers to assess their individual or combined value in the target population. Markers will be evaluated onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a centralized biobank of well-characterized specimens for use by IVD companies and academic institutions for the development and evaluation of emerging assays.
Any non-severely ill subject presenting with acute fever defined as: temperature of more than 38°C at initial evaluation of less than 7 days of symptoms at presentation.
For recruitment purposes, subjects will be classified into two groups:
Inclusion Criteria:
Any non-severely ill subject presenting with acute fever defined as: temperature of more than 38°C at initial evaluation of less than 7 days of symptoms at presentation.
Inclusion criteria:
For minors, caregivers will provide informed consent. Documented assent for children of 12 to 16 years of age will be required for their participation.
Exclusion Criteria:
Children and adults with fever presenting at the outpatient department
Diagnostic Test: Biomarker assay
Children and adults with fever presenting at the outpatient department
Diagnostic Test: Biomarker assay
Children with fever or with a recent history of fever presenting at the outpatient department
Diagnostic Test: Biomarker assay
There is no intervention on the patients but biomarker assays are being evaluated for their performance to distinguish bacterial infection from non-bacterial infections in febrile patients
Diagnostic sensitivity and specificity to determine bacterial infections compared to clinical and microbiological results aggregated in a study database.
Microbiological testing (blood culture positive/negative, malaria pos/neg, S. Tyhpi RDT pos/neg) and clinical assessments of symptoms (respiratory, gastro, no foci) will be recorded and reviewed by a clinical panel upon completion of the study to assign a final category (bacterial or non-bacterial). These categories are used in the evaluation of the biomarker assays to evaluate their performance in differentiating bacterial from non-bacterial infections. Where applicable, the same categories will be used to determine the area under the curve by employing receiver operator characteristics (ROC) analysis of quantitative markers.
Time frame: 1year
Plan to share: Yes — As appropriate data will be made available to the scientific community and/or commercial partners to support product development activities.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland