Procalcitonin for discontinuation of antibiotic therapy in clinically diagnosed Ventilator Associated Pneumonia

ISRCTN	ISRCTN61015974
DOI	https://doi.org/10.1186/ISRCTN61015974
Secondary identifying numbers	N/A

Submission date: 11/08/2006
Registration date: 01/09/2006
Last edited: 05/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Tamm
Scientific

University Hospital Basel
Clinic of Pneumology
Petersgraben 4
Basel
4031
Switzerland

Phone	+ 41 61 265 5184
Email	mtamm@uhbs.ch

Study information

Study design	Prospective multicentre randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	The ProVAP pilot study
Study objectives	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(s)	Committee for the Protection of Human Subjects in Research (FWA #00004009, docket #H-11990), EKBB Switzerland
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/07/2006
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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
Key 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)
Date of first enrolment	01/07/2006
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Basel

Basel
4031
Switzerland

Sponsor information

University Hospital Basel (Switzerland)
University/education

c/o Professor Michael Tamm
University Hospital Basel
Clinic of Pneumology
Petersgraben 4
Basel
4031
Switzerland

Phone	+ 41 61 261 5184
Email	mtamm@uhbs.ch
"ROR"	https://ror.org/04k51q396

Funders

Funder type

University/education

University Hospital Basel (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009	Yes	No
Results article	results	01/03/2011	Yes	No
Results article	results	01/10/2011	Yes	No