Procalcitonin as a Marker of Bacterial Pneumonia

COPD Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415753
• Other study ID #: 271-05-0765
• Status: Completed
• Phase: N/A
• First received: December 22, 2006
• Last updated: May 22, 2008
• Start date: June 2006
• Est. completion date: August 2007

Study information

• Verified date: May 2008
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: August 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bronchitis
• COPD
• Pneumonia

Intervention

Behavioral:
• No antibiotics if se-procalcitonin is below stated limit

Locations

Country	Name	City	State
Denmark	Department of Infectious Diseases, Skejby Hospital	Aarhus N
Denmark	Departement of Medicin, Silkeborg Hospital	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Müller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic use
Primary	Length of stay in hospital
Secondary	The proportion of patients where the doctor chooses to disregard treatment guidelines