A prospective study on the outcomes of prolonged fever and the prevalence of fever of unknown origi

Not Applicable

• Conditions: R50; Fever of other and unknown origin

• Registration Number: DRKS00009591
• Lead Sponsor: Abteilung für Rheumatologie Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-23
• Study Completion: 2017-04-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Febrile illness exceeding 37.8°C core temperature taken orally on at least three occasions over a minimum period of one week

Exclusion Criteria

Immunodeficiency, such as HIV, neutropenia or other immunocompromised states; Nosocomial fever; Patients below 18 years of age; Patients incpable of giving consent; Pregnant women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A post-hoc analysis of clinical (history, physical examination, chest X-ray, result of the naproxen test and the 18FDG-PET/CT) markers and biomarkers (erythrocyte sedimentation rate, blood count, differential blood count, chemistry, haemostasis, thyroid hormones, blood cultures, urinalysis, biomarkers for malignancy, infection, sepsis and autoimmunity) at baseline will be performed to identify potential predictors of outcome at study entry using principal component analysis. Thus, the main analysis (multiple regression of relevant markers) will have sufficent power to identify the independent effects of the most relevant markers, which may help modify / optimise clinical approach to patients with prolonged fever as well as FUO in the future.

Secondary Outcome Measures

Name	Time	Method
(1) The prevalence of true FUO<br>(2) The prevalence of the underlying causes of prolonged fever<br>(3) The Naproxen Test<br>We will consider a complete response as a drop in body temperature to <37.2°C.<br>(4) 18FDG-PET/CT<br>Based on the result of an 18FDG-PET/CT, additional diagnostic clues may appear and lead to additional diagnostic tests, which may or may not lead to a diagnosis. Based on the diagnostic status at the entering of Phase #2 and the diagnostic status after conclusion of Phase #2, the increase in diagnostic utility of 18FDG-PET/CT will be determined.