Combination therapy versus monotherapy: a randomised study on the evolution of inflammatory parameters after ventilator associated pneumonia

ISRCTN ISRCTN31976779
DOI https://doi.org/10.1186/ISRCTN31976779
Secondary identifying numbers N/A
Submission date
22/12/2005
Registration date
11/01/2006
Last edited
25/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Pierre Damas
Scientific

General Intensive Care Department
University Hospital
Domaine Universitaire du Sart-Tilman
Liege
4000
Belgium

Phone +32 (0)4 366 74 95
Email pdamas@chu.ulg.ac.be

Study information

Study designRandomised unblinded comparative study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes a combination antibiotic therapy of ventilator associated pneumonia improve the inflammatory parameters faster than a monotherapy?
Ethics approval(s)Yes; 27/02/02; 2002/32
Health condition(s) or problem(s) studiedVentilator associated pneumonia
InterventionComparison between treatment with cefepime alone and cefepime associated with amikacin or levofloxacin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cefepime, amikacin, levofloxacin
Primary outcome measureTime course evolution of C-reactive protein (CRP) levels, temperature and leucocytosis
Secondary outcome measures1. Length of ventilatory support
2. Evolution of PaO2/FiO2
3. Mortality
Overall study start date01/04/2002
Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants150
Key inclusion criteriaAdult patients with ventilator associated pneumonia
Key exclusion criteria1. Patients treated for other infection
2. Immunocompromised patients
3. Patients with life expectancy less than 72 hours
Date of first enrolment01/04/2002
Date of final enrolment31/12/2003

Locations

Countries of recruitment

  • Belgium

Study participating centre

General Intensive Care Department
Liege
4000
Belgium

Sponsor information

Domaine Universitaire du Sart-Tilman (Belgium)
University/education

Department of General Intensive Care
University Hospital
Domaine Universitaire du Sart-Tilman
Liege
4000
Belgium

Email pdamas@chu.ulg.ac.be
ROR logo "ROR" https://ror.org/00afp2z80

Funders

Funder type

University/education

Domaine Universitaire du Sart-Tilman (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2006 Yes No