POCT PCT in Outpatient LRTI

NCT05380869 | Completed

• 1 other identifier: 8736_MPG_23b2019
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Point-of-care test Procalcitonin for LRTI

OTHER

Diagnostic study, a POCT-PCT is done in all included patients

Diagnostic Test: Point-of-care Test

Interventions

Point-of-care Test DIAGNOSTIC_TEST

to test Point-of-care procalcitonin in suspected pneumonia

Point-of-care test Procalcitonin for LRTI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Medical School Hannover

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic study

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 19, 2022
• Study Start: April 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)