Clinical trial NCT03749226 - References

Ventilator Associated Pneumonia — Nebulized Aztreonam for Prevention of Gram Negative Ventilator-associated Pneumonia

Citation(s)

•   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.
•   Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group
  Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.
•   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.
•   Boukhettala N, Porée T, Diot P, Vecellio L
  In vitro performance of spacers for aerosol delivery during adult mechanical ventilation. J Aerosol Med Pulm Drug Deliv. 2015 Apr;28(2):130-6. doi: 10.1089/jamp.2013.1091. Epub 2014 Jul 22.
•   Chastre J, Fagon JY
  Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. Review.
•   Coates AL, Green M, Leung K, Chan J, Ribeiro N, Louca E, Ratjen F, Charron M, Tservistas M, Keller M
  Rapid pulmonary delivery of inhaled tobramycin for Pseudomonas infection in cystic fibrosis: a pilot project. Pediatr Pulmonol. 2008 Aug;43(8):753-9. doi: 10.1002/ppul.20850.
•   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. Review.
•   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.
•   Drakulovic MB, Bauer TT, Torres A, Gonzalez J, Rodríguez 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.
•   Dugernier J, Wittebole X, Roeseler J, Michotte JB, Sottiaux T, Dugernier T, Laterre PF, Reychler G
  Influence of inspiratory flow pattern and nebulizer position on aerosol delivery with a vibrating-mesh nebulizer during invasive mechanical ventilation: an in vitro analysis. J Aerosol Med Pulm Drug Deliv. 2015 Jun;28(3):229-36. doi: 10.1089/jamp.2014.1131. Epub 2014 Nov 13.
•   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. Review.
•   Gibson RL, Retsch-Bogart GZ, Oermann C, Milla C, Pilewski J, Daines C, Ahrens R, Leon K, Cohen M, McNamara S, Callahan TL, Markus R, Burns JL
  Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Pediatr Pulmonol. 2006 Jul;41(7):656-65.
•   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.
•   Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratalà J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL
  Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14. Erratum in: Clin Infect Dis. 2017 May 1;64(9):1298. Erratum in: Clin Infect Dis. 2017 Oct 15;65(8):1435. Clin Infect Dis. 2017 Nov 29;65(12):2161.
•   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. Review.
•   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. Review.
•   Martin-Loeches I, Povoa P, Rodríguez A, Curcio D, Suarez D, Mira JP, Cordero ML, Lepecq R, Girault C, Candeias C, Seguin P, Paulino C, Messika J, Castro AG, Valles J, Coelho L, Rabello L, Lisboa T, Collins D, Torres A, Salluh J, Nseir S; TAVeM study
  Inci
•   McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB
  Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med. 2008 Nov 1;178(9):921-8. doi: 10.1164/rccm.200712-1804OC. Epub 2008 Jul 24.
•   McKindley DS, Boucher BA, Hess MM, Croce MA, Fabian TC
  Pharmacokinetics of aztreonam and imipenem in critically ill patients with pneumonia. Pharmacotherapy. 1996 Sep-Oct;16(5):924-31.
•   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.
•   Nseir S, Ader F, Marquette CH
  Nosocomial tracheobronchitis. Curr Opin Infect Dis. 2009 Apr;22(2):148-53. doi: 10.1097/QCO.0b013e3283229fdb. Review.
•   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.
•   Nseir S, Povoa P, Salluh J, Rodriguez A, Martin-Loeches I
  Is there a continuum between ventilator-associated tracheobronchitis and ventilator-associated pneumonia? Intensive Care Med. 2016 Jul;42(7):1190-2. doi: 10.1007/s00134-016-4283-x. Epub 2016 Apr 1
•   Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson RL, McKevitt M, Montgomery AB
  Pseudomonas aeruginosa antibiotic susceptibility during long-term use of aztreonam for inhalation solution (AZLI). J Antimicrob Chemother. 2011 Oct;66(10):2398-404. doi: 10.1093/jac/dkr303. Epub 2011 Jul 22.
•   Palmer LB
  Ventilator-associated infection: the role for inhaled antibiotics. Curr Opin Pulm Med. 2015 May;21(3):239-49. doi: 10.1097/MCP.0000000000000160. Review.
•   Poulakou G, Siakallis G, Tsiodras S, Arfaras-Melainis A, Dimopoulos G
  Nebulized antibiotics in mechanically ventilated patients: roadmap and challenges. Expert Rev Anti Infect Ther. 2017 Mar;15(3):211-229. doi: 10.1080/14787210.2017.1268052. Epub 2017 Jan 2. Review.
•   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.
•   Rodríguez A, Barcenilla F
  Nebulized antibiotics. An adequate option for treating ventilator-associated respiratory infection? Med Intensiva. 2015 Mar;39(2):97-100. doi: 10.1016/j.medin.2014.10.006. Epub 2015 Feb 2. English, Spanish.
•   Rodríguez A, Cabrera M, Reyes LF, Bodí M, Trefler S, Canadell L, Barahona D, Ehrmann S, Martin-Loeches I, Restrepo MI, Vecellio L
  In vitro evaluation of aerosol delivery of aztreonam lysine (AZLI): an adult mechanical ventilation model. Expert Opin Drug
•   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, Thiébaut 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.

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

Details for clinical trial NCT03749226