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Completed

NCT Number: NCT00415753

Procalcitonin as a Marker of Bacterial Pneumonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Infectious Diseases, Skejby Hospital, Aarhus N, Denmark

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No antibiotics if se-procalcitonin is below stated limit

Behavioral

Primary outcomes

  1. Antibiotic use

  2. Length of stay in hospital

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 25, 2006
Registry last updated
May 23, 2008

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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