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OpenTrials
Completed

NCT Number: NCT05380869

POCT PCT in Outpatient LRTI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical School Hannover

Hanover, Lower Saxony, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point-of-care Test

Diagnostic Test

to test Point-of-care procalcitonin in suspected pneumonia

Primary outcomes

  1. Description of outpatients with lower respiratory tract infection

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Acronym: POCT-PCT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 19, 2022
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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