Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03749226
Status:
TERMINATED
Last Update Posted:
2021-07-01
First Post:
2018-04-20
Brief Title:
Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia
Sponsor:
Hospital Universitari Joan XXIII de Tarragona
Organization:
Hospital Universitari Joan XXIII de Tarragona
Study Overview
Official Title:
Efficacy Safety and Pharmacokinetics Profile of Nebulized Aztreonam Lysine AZLI for Prevention of Gram Negative Pneumonia in Heavily Colonized Mechanically Ventilated Patients
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to COVID-19 pandemia
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AZLIS
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 11 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 AZLIThe control group will not receive treatment
Prospective randomized 11 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 AZLIThe 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
1 Safety and tolerability of AZLI administered during 5 days in adults patients under mechanical ventilation heavily colonized by Gram-negative bacteria
2 The pharmacokinetic profile in endotracheal aspirate EA or bronchoalveolar lavage BAL
3 The plasma levels of nebulized AZLI in patients under mechanical ventilation heavily colonized by Gram-negative bacteria
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
1 Safety and tolerability of AZLI administered during 5 days in adults patients under mechanical ventilation heavily colonized by Gram-negative bacteria
2 The pharmacokinetic profile in endotracheal aspirate EA or bronchoalveolar lavage BAL
3 The plasma levels of nebulized AZLI in patients under mechanical ventilation heavily colonized by Gram-negative bacteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None