Gram negative pneumonia in heavily colonized mechanically ventilated patients MedDRA version: 20.0 Level: LLT Classification code 10035725 Term: Pneumonia NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Cayston
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: AZTREONAM LYSINE
CAS Number: 827611-49-4
Current Sponsor code: Cayston
Other descriptive name: AZTREONAM LYSINE
Concen
Sponsors
Alejandro Rodriguez Oviedo - Critical Care Department – Hospital Universitario de Tarragona Joan XXIII
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Patients under mechanical ventilation for more than 5 day 3. Patient with heavy colonization by Gram-negative microorganisms 4. No clinical suspicion of infections-related ventilator-associated complications (IVAC) according CDC criteria 5. Patients with ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments. 6. Informed consent signed 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 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 1. Suspected of IVAC. 2. Patients with known hypersensitivity to Aztreonam. 3. Patients who received more than 48 hours of broad spectrum antibiotics. 4. Evidence of active mycobacterium infections, chronic pulmonary infection or bronchial obstruction. 5. Granulomatous disease, lung cancer or lung transplant. 6. Acute respiratory distress syndrome (ARDS) 7.Woman who is pregnant or breast-feeding while enrolled in this study. 8. Any medical condition which, in the opinion of the Investigator, places the patient at an unacceptable risk for toxicities if entered into the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy (microbiological cure) of nebulized AZLI for the prevention of Gram-negative IVAC after 5 day of treatment.;Secondary Objective: - To determine safety and tolerability of nebulized AZLI in ventilated patients - To determine the pharmacokinetics profile of AZLI in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) in patients who received AZLI nebulized by a novel ultrasonic nebulizer (Aeroneb solo®) plus Combihaler® spacer at baseline, and 10 minutes, 2 hours and 4 hourss post-treatment . Determinations AZLI in respiratory samples will be made at day 1 and at day 2 of treatment. - To determine plasma Aztreonam levels at 9 time points on day 3 of treatment: before treatment, immediately post-treatment and at 0.5, 1, 2, 4 ,5, 6 and 8 hours post-treatment;Primary end point(s): To compare the microbiological cure at day-5 of treatment and the incidence of Gram-negative IVAC between 7th and 10th days after first dose in patients heavily colonized by Gram-negative bacteria treated with nebulized AZLI vs. no treatment.;Timepoint(s) of evaluation of this end point: The evaluation of primary endpoint will be on days 5, 7 and 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety and tolerability of AZLI administered during 5 days in adults patients under mechanical ventilation heavily colonized by Gram-negative bacteria - The pharmacokinetic profile in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) - The plasma levels of nebulized AZLI in patients under mechanical ventilation heavily colonized by Gram-negative bacteria.;Timepoint(s) of evaluation of this end point: - Safety and tolerability from day 1 to 10 - Pharmacokinetics days 1 and 2 - Plasma leves day 3 | — |
Countries
Spain
Contacts
Public ContactAlejandro Rodríguez Oviedo
Critical Care Department – Hospital Universitario de Tarragona Joan XXIII
Outcome results
None listed