Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia

• Status: Terminated
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Aerosol antibiotic administration offers the theoretical advantages of achieving high drug concentration at the infection site and low systemic absorption, thereby avoiding toxicity. Antibiotic aerosolization has good results in patients with cystic fibrosis, but data are scarce for patients under mechanical ventilation.

Prospective, randomized 1:1, open-label study to assess the microbiological cure and pharmacokinetics (PK), safety and efficacy of nebulized Aztreonam lysine (75 mg dose) each 8 hr during 5 days in ventilated patients heavily colonized by Gram-negative bacteria. It is planned to include a total of 20 ventilated patients heavily colonized. Only ten of them (active group) will receive 5 days of treatment with nebulized AZLI.The control group will not receive treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Joan XXIII de Tarragona.
• Treatments: Aztreonam

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 (Figure 1).

5. Patients or his/her legal representative 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

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