Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EA1/209/08
Study information
Scientific title
Implementation of De-Escalation Algorithm in patients with ventilator-associated pneumonia at two anaesthesiological intensive care units (ICUs) of Charité - University Medicine Berlin: a prospective observational single centre trial
Acronym
De-Escalation Algorithm
Study hypothesis
The implementation of evidence-based de-escalation algorithm in ventilator-associated pneumonia (VAP) will increase the rate of appropriate targeted antimicrobial therapy in order to improve patient outcomes.
Ethics approval
Ethics Committee of Charité - University Medicine Berlin approved on the 16th February 2009 (ref: EA1/209/08)
Study design
Prospective observational single centre cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ventilator-associated pneumonia
Intervention
After distribution of the de-escalation algorithm, clinician teams will be asked to treat the patients with suspicion of VAP according to algorithm. It will be left to their discretion, whether to adhere to the algorithm in whole or in part or not at all.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of patients with appropriate de-escalation according to VAP algorithm, assessed at the end of data collection.
Secondary outcome measures
1. Number of antibiotic-free days
2. Number of ventilator-free days
3. Number of organ dysfunctions
4. Length of ICU stay
5. Length of hospital stay
6. Rate of super-infections with multidrug resistant (MDR) species (P. aeruginosa, methicillin-resistant S. aureus etc.)
7. Therapy costs
All assessed at the end of data collection.
Overall trial start date
03/03/2009
Overall trial end date
03/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Intensive care unit (ICU) patients aged greater than 18 years, either sex
2. On mechanical ventilation for greater than or equal to 48 hours
3. Presenting with systemic inflammatory response syndrome (SIRS) and radiologically suggested new infiltrate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Aged less than 18 years
2. Other unknown infectious focus
3. Severe immune suppression (defined as corticosteroid doses of more than 7.5 mg of prednisolone equivalent for longer than 30 days, or other immuno-suppressive drugs)
4. Acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV)
5. Moribund patients
Recruitment start date
03/03/2009
Recruitment end date
03/03/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Augustenburger Platz 1
Berlin
13353
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Chariteplatz 1
Berlin
10117
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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
Basic results (scientific)
Publication list