Status:
TERMINATED
Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia
Lead Sponsor:
Hospital Universitari Joan XXIII de Tarragona.
Conditions:
Ventilator Associated Pneumonia
Prevention
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 aeroso...
Detailed Description
The main objectives of this study is: To compare the microbiological cure at day 5 of treatment and the incidence of Gram-negative IVAC between 7th and 10th days after last dose in patients heavily c...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Patients under mechanical ventilation for more than 5 day.
- Patient with heavy colonization by Gram-negative microorganisms.
- No clinical suspicion of infections-related ventilator-associated complications (IVAC) according CDC criteria (Figure 1).
- 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.
- Informed consent signed
Exclusion
- Suspected of IVAC.
- Patients with known hypersensitivity to Aztreonam.
- Patients who received more than 48 hours of broad spectrum antibiotics.
- Evidence of active mycobacterium infections, chronic pulmonary infection or bronchial obstruction.
- Granulomatous disease, lung cancer or lung transplant.
- Acute respiratory distress syndrome (ARDS)
- Woman who is pregnant or breast-feeding while enrolled in this study.
- 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
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03749226
Start Date
March 19 2019
End Date
December 31 2019
Last Update
July 1 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Critical Care Department - Hospital Universitario de Tarragona Joan XXIII
Tarragona, Spain, 43007