Condition category
Respiratory
Date applied
22/12/2005
Date assigned
11/01/2006
Last edited
25/09/2009
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 Pierre Damas

ORCID ID

Contact details

General Intensive Care Department
University Hospital
Domaine Universitaire du Sart-Tilman
Liege
4000
Belgium
+32 (0)4 366 74 95
pdamas@chu.ulg.ac.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Does a combination antibiotic therapy of ventilator associated pneumonia improve the inflammatory parameters faster than a monotherapy?

Ethics approval

Yes; 27/02/02; 2002/32

Study design

Randomised unblinded comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Ventilator associated pneumonia

Intervention

Comparison between treatment with cefepime alone and cefepime associated with amikacin or levofloxacin

Intervention type

Drug

Phase

Not Specified

Drug names

Cefepime, amikacin, levofloxacin

Primary outcome measures

Time course evolution of C-reactive protein (CRP) levels, temperature and leucocytosis

Secondary outcome measures

1. Length of ventilatory support
2. Evolution of PaO2/FiO2
3. Mortality

Overall trial start date

01/04/2002

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients with ventilator associated pneumonia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Patients treated for other infection
2. Immunocompromised patients
3. Patients with life expectancy less than 72 hours

Recruitment start date

01/04/2002

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Belgium

Trial participating centre

General Intensive Care Department
Liege
4000
Belgium

Sponsor information

Organisation

Domaine Universitaire du Sart-Tilman (Belgium)

Sponsor details

Department of General Intensive Care
University Hospital
Domaine Universitaire du Sart-Tilman
Liege
4000
Belgium
pdamas@chu.ulg.ac.be

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Domaine Universitaire du Sart-Tilman (Belgium)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16569261

Publication citations

  1. Results

    Damas P, Garweg C, Monchi M, Nys M, Canivet JL, Ledoux D, Preiser JC, Combination therapy versus monotherapy: a randomised pilot study on the evolution of inflammatory parameters after ventilator associated pneumonia [ISRCTN31976779]., Crit Care, 2006, 10, 2, R52, doi: 10.1186/cc4879.

Additional files

Editorial Notes