EUCTR2018-003865-32-ES
Active, not recruiting
Phase 1
Efficacy, safety and pharmacokinetics profile of nebulized Aztreonam Lysine (AZLI) for prevention of Gram negative pneumonia in heavily colonized mechanically ventilated patients: AZLIS - AZLIS
Alejandro Rodriguez Oviedo - Critical Care Department – Hospital Universitario de Tarragona Joan XXIII0 sites20 target enrollmentNovember 16, 2018
ConditionsGram negative pneumonia in heavily colonized mechanically ventilated patientsMedDRA version: 20.0Level: LLTClassification code 10035725Term: Pneumonia NOSSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsCayston
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Gram negative pneumonia in heavily colonized mechanically ventilated patients
- Sponsor
- Alejandro Rodriguez Oviedo - Critical Care Department – Hospital Universitario de Tarragona Joan XXIII
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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