POCT PCT in Outpatient LRTI (POCT-PCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia; Antimicrobial Stewardship; Exacerbation Copd; Lower Respiratory Tract and Lung Infections; Exacerbation of Allergic Asthma
• Intervention / Treatment: Diagnostic test: Point-of-care Test

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Medical School Hannover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Point-of-care test Procalcitonin for LRTI; Diagnostic study, a POCT-PCT is done in all included patients	Diagnostic test: Point-of-care Test; to test Point-of-care procalcitonin in suspected pneumonia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Procalcitonin; Antimicrobial stewardship; Point-of-care-Testing
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 8736_MPG_23b2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No