POCT PCT in Outpatient LRTI

Community-acquired Pneumonia Clinical Trial

— POCT-PCT  

Official title:

Point-of-care Procalcitonin Testing for Lower Respiratory Tract Infection in Outpatient Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380869
• Other study ID #: 8736_MPG_23b2019
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2022
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antimicrobial Stewardship
• Community-acquired Pneumonia
• Exacerbation Copd
• Infections
• Lower Respiratory Tract and Lung Infections

Intervention

Diagnostic Test:
• Point-of-care Test
to test Point-of-care procalcitonin in suspected pneumonia

Locations

Country	Name	City	State
Germany	Medical School Hannover	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of outpatients with lower respiratory tract infection	The study population will be described in terms of demographic characteristics using descriptive statistics.	up to 5 weeks
Primary	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.	For the diagnostic accuracy of the PCT the receiver operating characteristic (ROC) curves and the area under the curve (AUC) will be calculated.	up to 5 weeks