Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia (NCT03749226) | Clinical Trial Compass
TerminatedPhase 2/3
Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia
Stopped: due to COVID-19 pandemia
Spain9 participantsStarted 2019-03-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Microbiological cure
Timeframe: 5 days
Trial details
NCT IDNCT03749226
SponsorHospital Universitari Joan XXIII de Tarragona.
. 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