Ventilator Associated PneumoniaPhase 2/3AZLISNCT03749226

Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia

A Phase 2/3 study testing Aztreonam lysine, Aerogen Solo and CombiHaler in people with Ventilator Associated Pneumonia and Prevention, run by Hospital Universitari Joan XXIII de Tarragona. at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventilator Associated Pneumonia, Prevention, Respiratory Infection Other
What is being tested?: Aztreonam lysine, Aerogen Solo and CombiHaler
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteSpain
Study dates: 19 Mar 2019to 31 Dec 2019
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Critical Care Department - Hospital Universitario de Tarragona Joan XXIII
Tarragona, 43007

Other trials in Spain

About this study

Official title: Efficacy, Safety and Pharmacokinetics Profile of Nebulized Aztreonam Lysine (AZLI) for Prevention of Gram Negative Pneumonia in Heavily Colonized Mechanically Ventilated Patients

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.

Read the 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.

Conditions: Ventilator Associated Pneumonia, Prevention, Respiratory Infection Other
Being tested: Aztreonam lysine, Aerogen Solo, CombiHaler
Keywords: Nebulized antibiotic, Ventilator associated pneumonia, Ventilated associated tracheobronchitis, Aztreonam lysine
Medical subject headings: Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aztreonam lysineDrug
nebulization
Aerogen SoloDevice
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.
CombiHalerDevice
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.

Study groups in NCT03749226
Study group	Role	What they receive
AZLI group	Active comparator	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 Receives: Drug: Aztreonam lysine; Device: Aerogen Solo; Device: CombiHaler
Control group	No intervention	Patients assigned to control group will no receive any intervention for heavy Gram negative colonization

What is being measured

The primary outcome is the main question the study is designed to answer.

Microbiological cure
Microbiological cure was defined as endotracheal aspirate (EA) or BAL cultures with consistently negative results after five day of therapy.
Measured: 5 days

Secondary outcomes (9)

Pharmacokinetic of aztreonam lysine in respiratory samples
Maximum bronchial concentration[Cmax]
Measured: day 0 and day 2
Pharmacokinetic of aztreonam lysine in respiratory samples
time to maximum bronchial concentration[Tmax]
Measured: day 0 and day 2
Pharmacokinetic of aztreonam lysine in respiratory samples
Maximum bronchial concentration [Cmax] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Measured: day 0 and day 2
Pharmacokinetic of aztreonam lysine in respiratory samples
Area under the bronchial concentration-time curve [AUC] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Measured: day 0 and day 2
Pharmacokinetic of aztreonam lysine in respiratory samples
Terminal elimination half-time [t1/2] in tracheal aspirate (EA) or bronchoalveolar lavage (BAL) samples
Measured: day 0 and day 2
Pharmacokinetic profile of aztreonam lysine in serum samples
Time to maximum serum concentration[Tmax] in serum samples
Measured: day 3
Pharmacokinetic profile of aztreonam lysine in serum samples
Area under the serum concentration-time curve [AUC] in serum samples
Measured: day 3
Pharmacokinetic profile of aztreonam lysine in serum samples
Terminal elimination half-time [t1/2] in serum samples
Measured: day 3
SAEs and AEs assessments
adverse events as assessed by CTCAE v5.0
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 201931 Dec 2019

First posted21 Nov 2018
Study start19 Mar 2019
Primary completion4 Sep 2019
Study completion31 Dec 2019

Why it stopped: due to COVID-19 pandemia

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03749226
Sponsor's protocol ID: AZLI-2018-AR
Acronym: AZLIS
Status last verified: Jun 2021
First submitted: 20 Apr 2018
Last updated: 1 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Klompas M. Ventilator-associated events surveillance: a patient safety opportunity. Curr Opin Crit Care. 2013 Oct;19(5):424-31. doi: 10.1097/MCC.0b013e3283636bc9.
PubMed 23778075
File TM Jr. New diagnostic tests for pneumonia: what is their role in clinical practice? Clin Chest Med. 2011 Sep;32(3):417-30. doi: 10.1016/j.ccm.2011.05.011. Epub 2011 Jul 12.
PubMed 21867812
Niederman MS. Respiratory tract infections: advances in diagnosis, management and prevention. Clin Chest Med. 2011 Sep;32(3):xiii-xiv. doi: 10.1016/j.ccm.2011.07.001. No abstract available.
PubMed 21867811
Craven DE. Ventilator-associated tracheobronchitis (VAT): questions, answers, and a new paradigm? Crit Care. 2008;12(3):157. doi: 10.1186/cc6912. Epub 2008 Jun 18.
PubMed 18598373
Craven DE, Chroneou A, Zias N, Hjalmarson KI. Ventilator-associated tracheobronchitis: the impact of targeted antibiotic therapy on patient outcomes. Chest. 2009 Feb;135(2):521-528. doi: 10.1378/chest.08-1617. Epub 2008 Sep 23.
PubMed 18812452
Nseir S, Ader F, Marquette CH. Nosocomial tracheobronchitis. Curr Opin Infect Dis. 2009 Apr;22(2):148-53. doi: 10.1097/QCO.0b013e3283229fdb.
PubMed 19276882
Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
PubMed 11934711
Nseir S, Di Pompeo C, Pronnier P, Beague S, Onimus T, Saulnier F, Grandbastien B, Mathieu D, Delvallez-Roussel M, Durocher A. Nosocomial tracheobronchitis in mechanically ventilated patients: incidence, aetiology and outcome. Eur Respir J. 2002 Dec;20(6):1483-9. doi: 10.1183/09031936.02.00012902.
PubMed 12503708
American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
PubMed 15699079
Kollef MH, Hamilton CW, Montgomery AB. Aerosolized antibiotics: do they add to the treatment of pneumonia? Curr Opin Infect Dis. 2013 Dec;26(6):538-44. doi: 10.1097/QCO.0000000000000004.
PubMed 24126716
Venier AG, Leroyer C, Slekovec C, Talon D, Bertrand X, Parer S, Alfandari S, Guerin JM, Megarbane B, Lawrence C, Clair B, Lepape A, Perraud M, Cassier P, Trivier D, Boyer A, Dubois V, Asselineau J, Rogues AM, Thiebaut R; DYNAPYO study group. Risk factors for Pseudomonas aeruginosa acquisition in intensive care units: a prospective multicentre study. J Hosp Infect. 2014 Oct;88(2):103-8. doi: 10.1016/j.jhin.2014.06.018. Epub 2014 Aug 1.
PubMed 25155240
Drakulovic MB, Bauer TT, Torres A, Gonzalez J, Rodriguez MJ, Angrill J. Initial bacterial colonization in patients admitted to a respiratory intensive care unit: bacteriological pattern and risk factors. Respiration. 2001;68(1):58-66. doi: 10.1159/000050464.
PubMed 11223732
Azim A, Dwivedi M, Rao PB, Baronia AK, Singh RK, Prasad KN, Poddar B, Mishra A, Gurjar M, Dhole TN. Epidemiology of bacterial colonization at intensive care unit admission with emphasis on extended-spectrum beta-lactamase- and metallo-beta-lactamase-producing Gram-negative bacteria--an Indian experience. J Med Microbiol. 2010 Aug;59(Pt 8):955-960. doi: 10.1099/jmm.0.018085-0. Epub 2010 Apr 22.
PubMed 20413621
Horianopoulou M, Legakis NJ, Kanellopoulou M, Lambropoulos S, Tsakris A, Falagas ME. Frequency and predictors of colonization of the respiratory tract by VIM-2-producing Pseudomonas aeruginosa in patients of a newly established intensive care unit. J Med Microbiol. 2006 Oct;55(Pt 10):1435-1439. doi: 10.1099/jmm.0.46713-0.
PubMed 17005794
Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30. doi: 10.1056/NEJM199901073400104.
PubMed 9878641

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Ventilator Associated Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy, Safety and Pharmacokinetics Profile of Nebulized Aztreonam Lysine (AZLI) for Prevention of Gram Negative Pneumonia in Heavily Colonized Mechanically Ventilated Patients
ClinicalTrials.gov ID: NCT03749226
Acronym / sponsor ID: AZLIS / AZLI-2018-AR
Conditions: Ventilator Associated Pneumonia, Prevention, Respiratory Infection Other
Keywords: Nebulized antibiotic, Ventilator associated pneumonia, Ventilated associated tracheobronchitis, Aztreonam lysine
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: due to COVID-19 pandemia
Enrolment: 9 participants (actual)
Lead sponsor: Hospital Universitari Joan XXIII de Tarragona.University, hospital or other
Study start: 19 Mar 2019 (actual)
Primary completion: 4 Sep 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 21 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The main objectives of this study is:

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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

Arm	Type	Receives
AZLI group	Active comparator	Drug: Aztreonam lysine, Device: Aerogen Solo, Device: CombiHalerPatients 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
Control group	No intervention	–Patients assigned to control group will no receive any intervention for heavy Gram negative colonization

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aztreonam lysinenebulization	Drug	AZLI group
Aerogen SoloAerogen'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.	Device	AZLI group
CombiHalerThe 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.	Device	AZLI group

Primary outcome

Microbiological cure
Time frame: 5 days
Microbiological cure was defined as endotracheal aspirate (EA) or BAL cultures with consistently negative results after five day of therapy.

9 secondary outcomes

Pharmacokinetic of aztreonam lysine in respiratory samples
Time frame: day 0 and day 2
Pharmacokinetic of aztreonam lysine in respiratory samples
Time frame: day 0 and day 2
Pharmacokinetic of aztreonam lysine in respiratory samples
Time frame: day 0 and day 2
Pharmacokinetic of aztreonam lysine in respiratory samples
Time frame: day 0 and day 2
Pharmacokinetic of aztreonam lysine in respiratory samples
Time frame: day 0 and day 2
Pharmacokinetic profile of aztreonam lysine in serum samples
Time frame: day 3
Pharmacokinetic profile of aztreonam lysine in serum samples
Time frame: day 3
Pharmacokinetic profile of aztreonam lysine in serum samples
Time frame: day 3
SAEs and AEs assessments
Time frame: 10 days

Results and safety

The study was stopped early (reason given: due to COVID-19 pandemia). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
Background: PubMed 23778075Klompas M. Ventilator-associated events surveillance: a patient safety opportunity. Curr Opin Crit Care. 2013 Oct;19(5):424-31. doi: 10.1097/MCC.0b013e3283636bc9.
Background: PubMed 21867812File TM Jr. New diagnostic tests for pneumonia: what is their role in clinical practice? Clin Chest Med. 2011 Sep;32(3):417-30. doi: 10.1016/j.ccm.2011.05.011. Epub 2011 Jul 12.
Background: PubMed 21867811Niederman MS. Respiratory tract infections: advances in diagnosis, management and prevention. Clin Chest Med. 2011 Sep;32(3):xiii-xiv. doi: 10.1016/j.ccm.2011.07.001. No abstract available.
Background: PubMed 18598373Craven DE. Ventilator-associated tracheobronchitis (VAT): questions, answers, and a new paradigm? Crit Care. 2008;12(3):157. doi: 10.1186/cc6912. Epub 2008 Jun 18.
Background: PubMed 18812452Craven DE, Chroneou A, Zias N, Hjalmarson KI. Ventilator-associated tracheobronchitis: the impact of targeted antibiotic therapy on patient outcomes. Chest. 2009 Feb;135(2):521-528. doi: 10.1378/chest.08-1617. Epub 2008 Sep 23.
Background: PubMed 19276882Nseir S, Ader F, Marquette CH. Nosocomial tracheobronchitis. Curr Opin Infect Dis. 2009 Apr;22(2):148-53. doi: 10.1097/QCO.0b013e3283229fdb.
Background: PubMed 11934711Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
Background: PubMed 12503708Nseir S, Di Pompeo C, Pronnier P, Beague S, Onimus T, Saulnier F, Grandbastien B, Mathieu D, Delvallez-Roussel M, Durocher A. Nosocomial tracheobronchitis in mechanically ventilated patients: incidence, aetiology and outcome. Eur Respir J. 2002 Dec;20(6):1483-9. doi: 10.1183/09031936.02.00012902.
Background: PubMed 15699079American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
Background: PubMed 24126716Kollef MH, Hamilton CW, Montgomery AB. Aerosolized antibiotics: do they add to the treatment of pneumonia? Curr Opin Infect Dis. 2013 Dec;26(6):538-44. doi: 10.1097/QCO.0000000000000004.
Background: PubMed 25155240Venier AG, Leroyer C, Slekovec C, Talon D, Bertrand X, Parer S, Alfandari S, Guerin JM, Megarbane B, Lawrence C, Clair B, Lepape A, Perraud M, Cassier P, Trivier D, Boyer A, Dubois V, Asselineau J, Rogues AM, Thiebaut R; DYNAPYO study group. Risk factors for Pseudomonas aeruginosa acquisition in intensive care units: a prospective multicentre study. J Hosp Infect. 2014 Oct;88(2):103-8. doi: 10.1016/j.jhin.2014.06.018. Epub 2014 Aug 1.
Background: PubMed 11223732Drakulovic MB, Bauer TT, Torres A, Gonzalez J, Rodriguez MJ, Angrill J. Initial bacterial colonization in patients admitted to a respiratory intensive care unit: bacteriological pattern and risk factors. Respiration. 2001;68(1):58-66. doi: 10.1159/000050464.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: due to COVID-19 pandemia). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiological cure (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03749226, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.