Implementation of De-Escalation Algorithm in patients with ventilator-associated pneumonia at two anaesthesiological intensive care units (ICUs) of Charité - University Medicine Berlin

ISRCTN	ISRCTN80881420
DOI	https://doi.org/10.1186/ISRCTN80881420
Protocol serial number	EA1/209/08
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Submission date: 03/03/2009
Registration date: 29/06/2009
Last edited: 29/06/2009

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claudia Spies
Scientific

Augustenburger Platz 1
Berlin
13353
Germany

Study information

Primary study design	Observational
Study design	Prospective observational single centre cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
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
Study acronym	De-Escalation Algorithm
Study objectives	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(s)	Ethics Committee of Charité - University Medicine Berlin approved on the 16th February 2009 (ref: EA1/209/08)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Number of patients with appropriate de-escalation according to VAP algorithm, assessed at the end of data collection.
Key secondary outcome measure(s)	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.
Completion date	03/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	03/03/2009
Date of final enrolment	03/03/2010

Locations

Countries of recruitment

Germany

Study participating centre

Augustenburger Platz 1

Berlin
13353
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes