POCT-PCT: POCT PCT in Outpatient LRTI

Sponsor
Hannover Medical School (Other)
Overall Status
Completed
CT.gov ID
NCT05380869
Collaborator
(none)
114
1
1
12.9
8.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Point-of-care Test
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Diagnostic studyDiagnostic study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Point-of-care Procalcitonin Testing for Lower Respiratory Tract Infection in Outpatient Care
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Description of outpatients with lower respiratory tract infection [up to 5 weeks]

    The study population will be described in terms of demographic characteristics using descriptive statistics.

  2. 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. [up to 5 weeks]

    For the diagnostic accuracy of the PCT the receiver operating characteristic (ROC) curves and the area under the curve (AUC) will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical School Hannover Hannover Lower Saxony Germany 30625

Sponsors and Collaborators

  • Hannover Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT05380869
Other Study ID Numbers:
  • 8736_MPG_23b2019
First Posted:
May 19, 2022
Last Update Posted:
May 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hannover Medical School
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022