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Procalcitonin for discontinuation of antibiotic therapy in clinically diagnosed Ventilator Associated Pneumonia
ISRCTN ISRCTN61015974
DOI 10.1186/ISRCTN61015974
ClinicalTrials.gov identifier
EudraCT number
Public title Procalcitonin for discontinuation of antibiotic therapy in clinically diagnosed Ventilator Associated Pneumonia
Scientific title
Acronym The ProVAP pilot study
Serial number at source N/A
Study hypothesis We hypothesise that a Procalcitonin (ProCT) guided approach will increase the number of antibiotic-free days (for Ventilator Associated Pneumonia [VAP]) alive at 28 days by one third without compromising clinical outcomes.
Lay summary Not provided at time of registration
Ethics approval Committee for the Protection of Human Subjects in Research (FWA #00004009, docket #H-11990), EKBB Switzerland
Study design Prospective multicentre randomised controlled trial.
Countries of recruitment Switzerland
Disease/condition/study domain Ventilator associated pneumonia
Participants - inclusion criteria 1. Intensive Care Unit (ICU) patients who are intubated and have been mechanically ventilated for at least 48 hours
2. 18 years of age and older
3. Clinical suspicion of VAP based on clinical and radiological criteria (new or progressive radiographic infiltrate) plus at least two of three clinical features:
3.1. fever greater than 38°C
3.2. leukocytosis or leucopenia
3.3. purulent tracheal secretions
Participants - exclusion criteria 1. Pregnancy
2. Patients with coexisting, documented extrapulmonary infection diagnosed between days one and three that requires antibiotic therapy longer than three days
3. Previous long-term corticosteroid therapy (more than or equal to 0.5 mg/kg per day of prednisolone or equivalent for more than one month)
4. Severe immunosuppression (solid organ transplantation or stem cell transplant recipients, known Human Immunodeficiency Virus [HIV] infection, neutropenic patients and patients after chemotherapy)
Anticipated start date 01/07/2006
Anticipated end date 31/12/2008
Status of trial Completed
Patient information material
Target number of participants 100
Interventions In this study, all patients, irrespective of the randomisation group, will be treated with antibiotics for 72 hours.

1. In patients randomly assigned to the standard therapy group, antibiotics will be prescribed and discontinued based on the clinical stability, radiologic and laboratory findings as routinely performed in the treating facility. Serum and/or plasma samples for ProCT will be collected daily, and the treating physician will be blinded to the results of the ProCT level.

2. In patients randomly assigned to the ProCT group, the decision to discontinue antibiotic therapy will also be based on the clinical stability, radiologic and laboratory findings. However, in this group, a further assessment of the probability of bacterial infection using ProCT levels will be available. Antibiotic discontinuation will be recommended according to serum ProCT concentrations as follows:
2.1. strongly encouraged if less than 0.25 ug/L
2.2. encouraged if less than 0.5 ng/ml or a decrease more than or equal to 80% as compared to day zero values (or previous values)
2.3. discouraged if more than or equal to 0.5 ng/ml or a decrease less than or equal to 80% as compared to day zero values (or previous values)
2.4. strongly discouraged if more than or equal to 1 ug/L
Primary outcome measure(s) Number of antibiotic free-days (for VAP) alive within 28 days of clinically suspicion of VAP.
Secondary outcome measure(s) 1. Clinical deterioration (defined as an increase in Clinical Pulmonary Infection Score [CPIS] of more than two points)
2. Microbiologically documented pulmonary infection recurrence
3. The evolution of signs and symptoms potentially linked to pulmonary infection (fever, leukocyte counts, partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2], and radiological infiltrates)
4. Number of mechanical ventilation-free days at 28 days
5. The length of stay in the ICU within 30 days
6. In-hospital mortality up to 30 days
7. Mortality at 30 days
8. Percentage of patients in the ProCT group for whom treatment recommendations are followed
9. Correlation of other biomarkers and clinical course
Sources of funding University Hospital Basel (Switzerland)
Trial website
Publications 1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19797133
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20530040
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21835904
Contact name Prof  Michael  Tamm
  Address University Hospital Basel
Clinic of Pneumology
Petersgraben 4
  City/town Basel
  Zip/Postcode 4031
  Country Switzerland
  Tel + 41 61 265 5184
  Fax + 41 61 265 4587
  Email mtamm@uhbs.ch
Sponsor University Hospital Basel (Switzerland)
  Address c/o Professor Michael Tamm
University Hospital Basel
Clinic of Pneumology
Petersgraben 4
  City/town Basel
  Zip/Postcode 4031
  Country Switzerland
  Tel + 41 61 261 5184
  Fax + 41 61 265 4587
  Email mtamm@uhbs.ch
Date applied 11/08/2006
Last edited 05/10/2011
Date ISRCTN assigned 01/09/2006
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