The primary objective of this study is to validate the accuracy of FebriDx to discriminate between viral and/or bacterial respiratory infections. Besides this, the predictive value (negative predictive value (NPV) and positive predictive value (PPV…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Positive predictive value, negative predictive value, sensitivity and
specificity to detect and discriminate RTI caused by viral and or bacterial
pathogens.
Secondary outcome
not applicable
Background summary
Respiratory tract infections (RTI) are among the most important reasons for
antibiotic prescriptions in the western world. At the same time, antibiotics
are widely overused in RTI. Currently, it is hard to discriminate between viral
and bacterial RTI*s in the acute setting of the emergency department. Because
of this, patients that in hindsight appear to have a viral infection are
initially often treated with antibiotics. FebriDx was developed to encounter
this problem. A couple of pilot studies showed promising results with high
negative predictive values for bacterial RTI*s. Consequently, FebriDx might be
a useful tool to restrain antibiotic use and reducing bacterial resistance
towards antibiotics. However, FebriDx has not been validated in a Dutch
hospital setting.
Study objective
The primary objective of this study is to validate the accuracy of FebriDx to
discriminate between viral and/or bacterial respiratory infections. Besides
this, the predictive value (negative predictive value (NPV) and positive
predictive value (PPV)) of the FebriDx for bacterial and viral infections will
be determined.
Study design
Prospective, observational diagnostic accuracy study, with FebriDx test
performed at the ED via a fingerstick test.
Study burden and risks
The extra fingerstick blood samples will be drawn via the specific FebriDx
device. The burden of this device is comparable with regular fingerstick tests
and therefore negligible. Patients will not benefit from the FebriDx outcomes,
since the treating physicians will be blinded for the results.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- * 18 years of age;
- Presenting to the ED of the UMCU with suspected RTI for the internal medicine
department
- Febrile (temperature of >38.0 oC observed at presentation or reported fever
in past 72h)
- Patients need to be treated following the *Influenza zorgpad* of the UMCU
Exclusion criteria
No specific criteria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75075.041.20 |