Condition category
Respiratory
Date applied
11/08/2006
Date assigned
01/09/2006
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes