Back to resultsNebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia (AZLIS)
Primary Purpose
Ventilator Associated Pneumonia, Prevention, Respiratory Infection Other
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Aztreonam lysine
Aerogen Solo
CombiHaler
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring Nebulized antibiotic, Ventilator associated pneumonia, Ventilated associated tracheobronchitis, Aztreonam lysine
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Critical Care Department - Hospital Universitario de Tarragona Joan XXIII
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
AZLI group
Control group
Arm Description
Patients assigned to study group will receive nebulized Aztreonam lysine (AZLI 75 mg-dose) three times /day during 5 days by mean of the ultrasonic nebulizer (Aeroneb solo®) plus Combihaler® spacer adapted of the ventilator
Patients assigned to control group will no receive any intervention for heavy Gram negative colonization
Outcomes
Primary Outcome Measures
Microbiological cure
Microbiological cure was defined as endotracheal aspirate (EA) or BAL cultures with consistently negative results after five day of therapy.
Secondary Outcome Measures
Pharmacokinetic of aztreonam lysine in respiratory samples
Maximum bronchial concentration[Cmax]
Pharmacokinetic of aztreonam lysine in respiratory samples
time to maximum bronchial concentration[Tmax]
Pharmacokinetic of aztreonam lysine in respiratory samples
Maximum bronchial concentration [Cmax] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Pharmacokinetic of aztreonam lysine in respiratory samples
Area under the bronchial concentration-time curve [AUC] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Pharmacokinetic of aztreonam lysine in respiratory samples
Terminal elimination half-time [t1/2] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Pharmacokinetic profile of aztreonam lysine in serum samples
Time to maximum serum concentration[Tmax] in serum samples
Pharmacokinetic profile of aztreonam lysine in serum samples
Area under the serum concentration-time curve [AUC] in serum samples
Pharmacokinetic profile of aztreonam lysine in serum samples
Terminal elimination half-time [t1/2] in serum samples
SAEs and AEs assessments
adverse events as assessed by CTCAE v5.0
Full Information
NCT ID
NCT03749226
First Posted
April 20, 2018
Last Updated
June 29, 2021
Sponsor
Hospital Universitari Joan XXIII de Tarragona.
1. Study Identification
Unique Protocol Identification Number
NCT03749226
Brief Title
Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia
Acronym
AZLIS
Official Title
Efficacy, Safety and Pharmacokinetics Profile of Nebulized Aztreonam Lysine (AZLI) for Prevention of Gram Negative Pneumonia in Heavily Colonized Mechanically Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
due to COVID-19 pandemia
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
September 4, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari Joan XXIII de Tarragona.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
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 colonized by Gram-negative bacteria treated with nebulized AZLI vs. no treatment.
The secundary objective of this study are:
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 endotracheal aspirate (EA) or bronchoalveolar lavage (BAL).
The plasma levels of nebulized AZLI in patients under mechanical ventilation heavily colonized by Gram-negative bacteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Prevention, Respiratory Infection Other
Keywords
Nebulized antibiotic, Ventilator associated pneumonia, Ventilated associated tracheobronchitis, Aztreonam lysine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Twenty consecutive patients heavily colonized by Gram-negative bacteria will be eligible for this study. Patients will be randomized to receive either AZLI nebulized or nothing via 1:1 randomization at study or control group.
Patients assigned to study group will receive nebulized Aztreonam lysine (AZLI 75 mg-dose) three times /day during 5 days by mean of the ultrasonic nebulizer (Aeroneb solo®) plus Combihaler® spacer adapted of the ventilator. All patients will be on conventional volume-control ventilator setting during the antibiotic therapy. Systemic antibiotics will not be used in any patient. If the attending physician saw the need to administer intravenous antibiotics after the patient has entry in the study, this patients should be removed from the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZLI group
Arm Type
Active Comparator
Arm Description
Patients assigned to study group will receive nebulized Aztreonam lysine (AZLI 75 mg-dose) three times /day during 5 days by mean of the ultrasonic nebulizer (Aeroneb solo®) plus Combihaler® spacer adapted of the ventilator
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients assigned to control group will no receive any intervention for heavy Gram negative colonization
Intervention Type
Drug
Intervention Name(s)
Aztreonam lysine
Intervention Description
nebulization
Intervention Type
Device
Intervention Name(s)
Aerogen Solo
Intervention Description
Aerogen's vibrating mesh technology, available within the Aerogen® Solo has been adopted for use of conventional mechanical ventilation. Aerogen Solo utilizes active vibrating mesh technology, where energy applied to the vibrational element, causes vibration of each of the 1000 funnel shaped apertures within the mesh. The mesh acts as a micropump drawing liquid through the holes producing a low velocity aerosol optimized for targeted drug delivery to the lungs. According our study (Rodriguez A et al , Expert Opin Drug Deliv. 2017 Dec;14(12):1447-1453) Aeroneb Solo showed an excellent aerosol delivery profile for Aztreonam lysine (AZLI) in an in vitro model of MV with short drug delivery time.
Intervention Type
Device
Intervention Name(s)
CombiHaler
Intervention Description
The inhalation chamber CombiHaler™ spacer for mechanical ventilation and critical care (ICU) allows using both a vibrating mesh nebulizer such as Aeroneb ™, and a pMDI. It saves 50% of the nebulized drug when used in invasive ventilation. The inhalation chamber CombiHaler® is integrated on a circuit of a breathing device in invasive ventilation in particular for connexion of an Aeroneb® Pro or an Aeroneb® Solo. According our study (Rodriguez A et al , Expert Opin Drug Deliv. 2017 Dec;14(12):1447-1453) a better aerosol delivery performance (30%) was obtained using the Conbihaler spacer.
Primary Outcome Measure Information:
Title
Microbiological cure
Description
Microbiological cure was defined as endotracheal aspirate (EA) or BAL cultures with consistently negative results after five day of therapy.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic of aztreonam lysine in respiratory samples
Description
Maximum bronchial concentration[Cmax]
Time Frame
day 0 and day 2
Title
Pharmacokinetic of aztreonam lysine in respiratory samples
Description
time to maximum bronchial concentration[Tmax]
Time Frame
day 0 and day 2
Title
Pharmacokinetic of aztreonam lysine in respiratory samples
Description
Maximum bronchial concentration [Cmax] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Time Frame
day 0 and day 2
Title
Pharmacokinetic of aztreonam lysine in respiratory samples
Description
Area under the bronchial concentration-time curve [AUC] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Time Frame
day 0 and day 2
Title
Pharmacokinetic of aztreonam lysine in respiratory samples
Description
Terminal elimination half-time [t1/2] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Time Frame
day 0 and day 2
Title
Pharmacokinetic profile of aztreonam lysine in serum samples
Description
Time to maximum serum concentration[Tmax] in serum samples
Time Frame
day 3
Title
Pharmacokinetic profile of aztreonam lysine in serum samples
Description
Area under the serum concentration-time curve [AUC] in serum samples
Time Frame
day 3
Title
Pharmacokinetic profile of aztreonam lysine in serum samples
Description
Terminal elimination half-time [t1/2] in serum samples
Time Frame
day 3
Title
SAEs and AEs assessments
Description
adverse events as assessed by CTCAE v5.0
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Critical Care Department - Hospital Universitario de Tarragona Joan XXIII
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia
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