Clinical trial to evaluate the efficacy, safety and pharmacokinetics profile of nebulized Aztreonam Lysine (AZLI) for prevention of Gram negative pneumonia in heavily colonized mechanically ventilated patients

Phase 1

• Conditions: Gram negative pneumonia in heavily colonized mechanically ventilated patients; MedDRA version: 20.0Level: LLTClassification code 10035725Term: Pneumonia NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-003865-32-ES
• Lead Sponsor: Alejandro Rodriguez Oviedo - Critical Care Department – Hospital Universitario de Tarragona Joan XXIII

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-16
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified