Randomized, open label, multicenter trial to compare safety and efficacy of colistin vs. meropenem for empirical treatment of ventilator-associated pneumonia

Conditions: VAP PATIENTS AT RISK FOR GRAM-NEGATIVE MDR PATHOGENS ISOLATION
MedDRA version: 14.1Level: LLTClassification code 10035701Term: Pneumonia gram-negative bacterial NOSSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2010-023310-31-IT

Lead Sponsor: CONSORCIO DE APOYO A LA INVESTIGACION BIOMEDICA EN RED (CAIBER)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Age = 18 years
-To be included, each patient must fulfill the following criteria:
1.Consecutive adults who had received mechanical ventilation in the ICU
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for at least 4 days.
2.Clinical and radiological criteria of VAP.
3.Suspicion of multi-resistant gram-negative bacillus as cause of the
VAP.
4.Clinical Pulmonary Infection Store (CPIS) > 6.
5.Respiratory secretion sample obtained from the respiratory tract by
means of bronchoscope with broncoalveolar washing (BAL) or bronchial
aspirates, both quantitatively processed obtained in the 24 h. previous to
the beginning of antimicrobial treatment of the study.
6.The women of childbearing age (not surgically sterilized and in the
period between menarche and 1 year after the menopause) must have a
negative test of pregnancy in urine at the time of recruitment.
7.The patient or his/her legal representative must sign a document of
informed consent approved by the Ethics Review Committee.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

-Renal insufficiency in substitute treatment.
-Corporal weight <40 kg or >150 kg.
-Patients currently included in another clinical trial.
-Refractory shock or another disease that, according to the researcher,
presents a life expectancy inferior to 48 hours, after the recruitment.
-Known allergy or hyper sensibility to meropenem or any excipients
-Known allergy or hyper sensibility to any carbapenem
-Serious hyper sensibility (anaphylactic reaction or serious skin
reaction) to any betalactam (peniciline or cephalosporins)
-Known allergy or hyper sensibility to colistine
-Colistin reduces pre-synaptic release of acetylcholine at the
neuromuscular junction; this is why it should not be administered in
patients with Miastenia Gravis.
-