ventilator associated pneumonia or ventilator associated tracheobronchitis or health-care associated pneumonia or hospital acquired pneumonia MedDRA version: 21.1 Level: PT Classification code 10044314 Term: Tracheobronchitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: LLT Classification code 10035701 Term: Pneumonia gram-negative bacterial NOS System Organ Class: 10021881 - Infections and infestations MedDRA version: 22.0 Level: LLT Classification c
Conditions
Interventions
Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML
Product Name: COLIMICINA
Pharmaceutical Form: Po
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - inpatients at U.O. of Anesthesia and Reanimation B - AOUI Verona - age> 18 years - both sexes; - both women of childbearing age who taking contraceptives and who do not use them - patients affected by HAP / HCAP / VAP / VAT - patients subjected to invasive ventilation - isolation from deep respiratory secretions of A.baumannii and / or P. aeruginosa sensitive to no more than two classes of antibiotics, one of which is represented by polymyxins (XDR) and / or Enterobacteriaceae resistant to carbapenems and sensitive to polymyxins (MDR or XDR), according to the following quantitative parameters: - BAL (broncho-alveolar lavage):> 104 CFU / mL in the course of HAP / HCAP / VAP - BAS (broncoaspirate):> 106 CFU / mL in the course of HAP / HCAP / VAP / VAT; > 105 CFU / mL in the course of VAT or patient known to be colonized intestinally (rectal surveillance buffer) or pharyngeal (surveillance pharyngeal swab) from the above-mentioned bacterial agents and waiting for the outcome of the BAL / BAL culture tests N.B: all the microbiological tests must not have been performed more than one week before enrollment - written informed consent by the patient (if the patient is unable to provide it at the beginning of the study, it will be obtained as soon as possible). If the patient is unable to provide consent, a legal representative of the subject is required to sign it. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Pregnancy and breastfeeding - Intermittent dialysis or CRRT (continuous renal replacement therapy) - Concomitant enlistment in other research protocols - Known intolerance to colistimethate sodium and / or to any of the excipients - Use of intravenous colistimetate sodium and / or aerosol 7 days prior to enrollment - Personal history or family history of myasthenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Description of colistin intra-pulmonary and plasma pharmacokinetics in patients with HCAP, HAP, VAP or VAT sustained by MDR-GNB or XDR-GNB and treated with colistimethate sodium administered either intravenously or by intravenous and aerosol route. 2. To describe the safety of treatment with colistimethate sodium administered exclusively by parenteral route compared to treatment with colistimethate sodium administered both by parenteral route and aerosol.;Secondary Objective: 1. To describe the microbiological success in patients treated with colistimetate sodium exclusively intravenously and in those treated with colistimetate sodium both intravenously and aerosol. 2. To describe the clinical success (improvement of respiratory exchanges and / or radiographic images and / or laboratory parameters and / or thermal curve) of patients treated with colistimethate sodium exclusively by parenteral route and in those treated with colistimethate sodium parenterally and aerosol. 3. To describe the mortality of patients enrolled in the two arms of the study at the end-of-treatment (EOT), that is after a maximum of 14 days of therapy, and 14 days after EOT;Primary end point(s): Pharmacokinetic parameters obtained by measuring the colistin intrapulmonary and plasma concentration: AUC, Cmax, Tmax, T1 / 2, Volume of distribution and Clearance. 2. Description of the safety of the treatment, evaluating the appearance of any adverse event (AE), adverse reaction (ADR), serious adverse event (SAE) about: - renal function (plasma creatinine, creatinine clearance in 24 h) - the appearance of hypersensitivity reactions such as rash and angioedema; - the appearance of psychiatric disorders such as confusion, psychosis; - the appearance of neurotoxic effects such as paresthesia, dizziness, tingling at the extremities and the tongue, language disorder and imbalance of the autonomic nervous system, neuromuscular block to apnea. - the appearance, in patients treated also w | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 7-10 giorni dall¿inizio della terapia - 48 h dall¿inizio della terapia ; Description of clinical success, as improvement of respiratory exchanges (pCO2, pO2, pO2 / FiO2) and / or radiographic images (chest X-ray and / or chest CT) and / or laboratory parameters (blood count with formula, PCR, PCT) and / or and of the thermal curve of patients enrolled in both arms of the study, by clinical / bio-humoral and instrumental assessment ; all¿EOT e dopo 14 giorni dall¿EOT;Timepoint(s) of evaluation of this end point: - 7-10 days from the start of therapy - 48 h from the start of therapy; during treatment, at the end of treatment (EOT) and after 14 days from EOT; at EOT and 14 days after EOT | — |
Countries
Italy
Contacts
Public ContactUnit¿ Ricerca Clinica
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed