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 |
| Protocol serial number | N/A |
| Sponsor | Domaine Universitaire du Sart-Tilman (Belgium) |
| Funder | Domaine Universitaire du Sart-Tilman (Belgium) |
- 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
Scientific
General Intensive Care Department
University Hospital
Domaine Universitaire du Sart-Tilman
Liege
4000
Belgium
| Phone | +32 (0)4 366 74 95 |
|---|---|
| pdamas@chu.ulg.ac.be |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised unblinded comparative study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does 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) studied | Ventilator associated pneumonia |
| Intervention | Comparison between treatment with cefepime alone and cefepime associated with amikacin or levofloxacin |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cefepime, amikacin, levofloxacin |
| Primary outcome measure(s) |
Time course evolution of C-reactive protein (CRP) levels, temperature and leucocytosis |
| Key secondary outcome measure(s) |
1. Length of ventilatory support |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | Adult patients with ventilator associated pneumonia |
| Key exclusion criteria | 1. Patients treated for other infection 2. Immunocompromised patients 3. Patients with life expectancy less than 72 hours |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- Belgium
Study participating centre
General Intensive Care Department
Liege
4000
Belgium
4000
Belgium
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? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2006 | Yes | No |
