Clinical trial NCT05380869: POCT PCT in Outpatient LRTI
Official title: Point-of-care Procalcitonin Testing for Lower Respiratory Tract Infection in Outpatient Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antimicrobial Stewardship
Exacerbation of Allergic Asthma
Exacerbation Copd
Community-acquired Pneumonia
Lower Respiratory Tract and Lung Infections
Keywords: Procalcitonin
Point-of-care-Testing
Antimicrobial stewardship
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Diagnostic study
Primary purpose: DIAGNOSTIC

Brief summary: Lower respiratory tract infections (LRTI) in patients with chronic lung diseases are a common acute reason to consult respiratory practitioners and often lead to inadequate prescription of antibiotics. The primary objective of the investigators study was to determine the diagnostic accuracy of point-of-care testing (POCT) for procalcitonin (PCT) in identifying pneumonia as a bacterial infection in outpatients with LRTI.

Detailed description: Lower respiratory tract infections (LRTI) are a common acute reason to consult general practitioners or lung specialists and most patients receive an antibiotic prescription. Despite the vast majority of LRTI are caused by viruses, the lack of clinical, radiological, and laboratory tests to safely rule out bacterial involvement in LRTI still drives antibiotic treatment today Procalcitonin (PCT) has been shown to be a useful biomarker for differentiating between viral and bacterial infections in the emergency department and is now available as a point-of-care testing (POCT). The primary objective of the investigators study was to determine the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI. All patients aged 18 years or older with signs and symptoms of an LRTI as the leading diagnosis of the respiratory physicians are eligible. The medical assistant measure PCT from venous or capillary whole blood using the portable commercially available BRAHMS PCT direct point-of-care test (Thermo-Fischer Scientific). The stepwise procedure involve pipetting 20µl of the sample into the test disc before loading this onto the analyzer and pressing run. This immunoassay provides a quantitative result in 20 minutes. In suspicion of pneumonia (positive auscultation finding or clinical noticed symptoms compatible with pneumonia) a chest x-ray will be done. Members of the study team conduct standardised phone interviews of all participants on day 28.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Clinical diagnosis of lower respiratory tract infection

Exclusion Criteria:

* Active malignancies
* Cystic fibrosis
* Solid organ or stem cell transplantation
* Chronic infection (endocarditis, osteomyelitis, active tuberculosis)
* Pregnancy

Primary outcomes:
measure: Description of outpatients with lower respiratory tract infection
timeFrame: up to 5 weeks
measure: Determining the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI using portable commercially available BRAHMS PCT direct point-of-care test.
timeFrame: up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
state: Lower Saxony
Study officials:
References: