|- candidate number||5932|
|- NTR Number||NTR1861|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-jun-2009|
|- Secondary IDs||METC 09/083 VUmc|
|- Public Title||Het staken van antiobiotica op geleide van een biomarker, procalcitonine bij volwassen patienten opgenomen op de intensive care unit.|
|- Scientific Title||Stop Antibiotics on Procalcitonin guidance Study.|
|- hypothesis||Whether antibiotic guidance by procalcitonin measurements are able to reduce antibiotic usage and duration in Dutch intensive care units. |
|- Healt Condition(s) or Problem(s) studied||Intensive Care (IC) patients, Antibiotics, Biomarkers, Procalcitonin|
|- Inclusion criteria||Any patient over the age of 18, admitted to the ICU and receiving antibiotics for an assumed infection can be enrolled into this trial. Informed consent has to be obtained in writing from the patient of his/her relatives prior to inclusion.
|- Exclusion criteria||1. Failure to obtain written consent to participate;|
2. Patients receiving prolonged antibiotic therapies (> 3 weeks, e.g. endocarditis);
3. Patients with severe infections due to viruses or parasites;
4. Patients entering the ICU for post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs;
5. Patients suffering from plasmodium falciparum malaria, active tuberculosis or cystic fibrosis;
6. Neutropenic patients;
7. Moribund patients.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2009|
|- planned closingdate||1-mrt-2010|
|- Target number of participants||2246|
|- Interventions||When procalcitonin has reached a peaklevel of above 1,0 ng/ml and the value has decreased to below 0,25 ng/ml, there will be adviced to stop antibiotics (absolute decrease). |
A second intervention rule is with a decrease of 90% of the peak value there will also be advised to stop antibiotics (relative decrease).
When the procalcitonin peaklevel is below 1.0 ng/ml, a decrease to below 0.1 ng/ml is needed, before there will be advised to stop antibiotics (absolute decrease).
|- Primary outcome||1. Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. In case of multiple antibiotic therapies the therapy that will be used the longest will be scored in duration of therapy;|
2. 28-day mortality.
|- Secondary outcome||1. The percentage of new episodes of bacterial infections for which antibiotics are prescribed per 1.000 ICU days;|
2. Length of ICU stay, measured after discharge from the ICU in days;
3. Acquisition costs of antibiotics (in Euro’s);
4. Costs of procalcitonin (in Euro’s).
|- Timepoints||An interim analysis will be performed after enrolment of the first 750 patients.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| E. Jong, de|
|- CONTACT for SCIENTIFIC QUERIES||dr. A. Beishuizen|
|- Sponsor/Initiator ||VU University Medical Center, Department of Intensive Care|
(Source(s) of Monetary or Material Support)
|VU Medical Center, Intensive Care Adults|
|- Brief summary||In all patients antibiotics will be started based on a clinical suspicion of infection or microbiological evidence of an organism. This decision is fully at the discretion of the team and should be made in the same way during the trial as under. Once antibiotics are administered for suspected or proven bacterial infection, a serum sample (T0) will be obtained and patients or their next of kin be asked for informed consent. If informed consent is obtained, the patient will be randomized to the standard therapy arm (control group) or the procalcitonin (intervention) arm. Randomization will be stratified for diagnostic group and centre. If a patient is randomized for the control group, no procalcitonin measurements will be performed. If a patient is randomized for the procalcitonin group, procalcitonin will be measured in the T0-serum sample. On the following days the treating physician will be given daily procalcitonin values until ICU-discharge or until the third day after al systemic antibiotics have been discontinued. Along with daily procalcitonin values the physician will also receive a printed, non-binding advice to consider stopping the prescribed antibiotics if procalcitonin has decreased to 90 % of its peak value measured during this episode or has dropped bellowed the defined values specified in the stopping rules. As for the control group, the physician will receive daily laboratory values as requested and no additional advice. |
|- Main changes (audit trail)|
|- RECORD||12-jun-2009 - 6-okt-2009|