Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00415753
NCT00415753CompletedNot Applicable

Procalcitonin as a Marker of Bacterial Pneumonia

Aarhus University Hospital Skejby4 sites in 1 country223 target enrollmentStarted: June 1, 2006Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
223
Locations
4
Primary Endpoint
Antibiotic use
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment.

The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice.

The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •suspected lower respiratory tract infection
  • •must be able to give consent

Exclusion Criteria

  • •age under 18 years
  • •not able to give consent
  • •admitted not primarily because of the respiratory tract infection
  • •hospital acquired infections

Outcomes

Primary Outcomes

Antibiotic use

Length of stay in hospital

Secondary Outcomes

  • The proportion of patients where the doctor chooses to disregard treatment guidelines

Investigators

Sponsor
Aarhus University Hospital Skejby
Sponsor Class
Other

Study Sites (4)

Loading locations...

Similar Trials

Completed
Not Applicable
Procalcitonin (PCT) as a Diagnostic Marker of Bacterial Infection in the Patients Admitted for Fever and/or Inflammatory Syndrome to the Internal Medicine DepartmentFeverSystemic Inflammatory Response Syndrome
NCT02898948Centre Hospitalier Universitaire, Amiens116
Unknown
Not Applicable
Use of Procalcitonin in the Diagnosis of Pleural EffusionPleural Effusion
NCT00172835National Taiwan University Hospital100
Completed
Not Applicable
Procalcitonin Levels in Patients With Fever and a Central LineFever
NCT01175005Phoenix Children's Hospital62
Completed
Not Applicable
Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver TransplantLiver Transplant Infection
NCT03389360National Hepatology & Tropical Medicine Research Institute60
Unknown
Phase 4
Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract InfectionsAcute Exacerbation of Chronic Obstructive Airways DiseasePneumonia
NCT02171338Holbaek Sygehus55