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
-
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.