Procalcitonin as a Marker of Bacterial Pneumonia

NCT00415753 | Completed

• 1 other identifier: 271-05-0765
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumonia; Bronchitis; COPD

Outcome Measures

Primary Outcomes (2)

• Antibiotic use

• Length of stay in hospital

Secondary Outcomes (1)

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

Interventions

No antibiotics if se-procalcitonin is below stated limit BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (2)

Department of Infectious Diseases, Skejby Hospital

Aarhus N, 8200, Denmark

Location

Departement of Medicin, Silkeborg Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (2)

• Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller 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. doi: 10.1016/S0140-6736(04)15591-8.

  PMID: 14987884 BACKGROUND

• Kristoffersen KB, Sogaard OS, Wejse C, Black FT, Greve T, Tarp B, Storgaard M, Sodemann M. Antibiotic treatment interruption of suspected lower respiratory tract infections based on a single procalcitonin measurement at hospital admission--a randomized trial. Clin Microbiol Infect. 2009 May;15(5):481-7. doi: 10.1111/j.1469-0691.2009.02709.x. Epub 2009 Mar 5.

  PMID: 19416298 DERIVED

MeSH Terms

Conditions

Pneumonia; Bronchitis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Finn T Black, Professor

  Aarhus Universityhospital

  STUDY CHAIR

• Kristina B Kristoffersen

  Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2006
• First Posted: December 25, 2006
• Study Start: June 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: August 1, 2007
• Last Updated: May 23, 2008

Record last verified: 2008-05

Locations

DK (2)