Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia
Status:
Terminated
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
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.