Condition category
Respiratory
Date applied
03/03/2009
Date assigned
29/06/2009
Last edited
29/06/2009
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 Claudia Spies

ORCID ID

Contact details

Augustenburger Platz 1
Berlin
13353
Germany

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 measures

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

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

http://www.charite.de/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes