Contact information
Type
Scientific
Primary contact
Prof Michael Tamm
ORCID ID
Contact details
University Hospital Basel
Clinic of Pneumology
Petersgraben 4
Basel
4031
Switzerland
+ 41 61 265 5184
mtamm@uhbs.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
The ProVAP pilot study
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.
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ventilator associated pneumonia
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Number of antibiotic free-days (for VAP) alive within 28 days of clinically suspicion of VAP.
Secondary outcome measures
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
Overall trial start date
01/07/2006
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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)
Recruitment start date
01/07/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Basel
Basel
4031
Switzerland
Sponsor information
Organisation
University Hospital Basel (Switzerland)
Sponsor details
c/o Professor Michael Tamm
University Hospital Basel
Clinic of Pneumology
Petersgraben 4
Basel
4031
Switzerland
+ 41 61 261 5184
mtamm@uhbs.ch
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Hospital Basel (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Results
Boeck L, Eggimann P, Smyrnios N, Pargger H, Thakkar N, Siegemund M, Marsch S, Rakic J, Tamm M, Stolz D, Midregional pro-atrial natriuretic peptide and procalcitonin improve survival prediction in VAP., Eur. Respir. J., 2011, 37, 3, 595-603, doi: 10.1183/09031936.00023810.
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Results
Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D, Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia., Chest, 2011, 140, 4, 925-932, doi: 10.1378/chest.11-0018.
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Stolz D, Smyrnios N, Eggimann P, Pargger H, Thakkar N, Siegemund M, Marsch S, Azzola A, Rakic J, Mueller B, Tamm M, Procalcitonin for reduced antibiotic exposure in ventilator-associated pneumonia: a randomised study., Eur. Respir. J., 2009, 34, 6, 1364-1375, doi: 10.1183/09031936.00053209.