Aztreonam cystic fibrosis

McCoy KS, Quitmer AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. (2008) Inhaled aztreonam lysine for chronic airway Pseudomonas Aeruginosa in cystic fibrosis. Am J Respir Crit Care Med 178 921-928. 

Retsch-Bogart GZ, Bums JL, Otto KL, Liou TG McCoy K, Oennann C, Gibson RL. (2008) A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas Aeruginosa infection. Pediatr Pulmonol 43 47-58. 

Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, Cooper PJ. (2009) Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest 135 1223-1232. 

Children Safety and efficacy of IV aztreonam have been established children 9 months to 16 years of age. Sufficient data are not available for pediatric patients younger than 9 months of age or for treatment of the following indications/pathogens Septicemia and skin and skin-structure infections (where the skin infection is caused by H. influenzae type b). In pediatric patients with cystic fibrosis, higher doses of aztreonam may be warranted. 

Since that time, a significant number of variations on that theme have been placed into clinical trials and, in some cases, such as Aztreonam 28, into commerce. Recently (late 2007, early 2008), this compound was submitted for approval in the EU and the USA as the lysinate salt for the inhalation treatment of Pseudomonas aeruginosa in cystic fibrosis under an Orphan drug category. As of late 2008, the Food and Drug Administration (FDA) was requiring further information and the status of the EU application was not yet known. 

Koch C, Hjelt K, Pedersen SS, Jensen ET, Jensen T, Lanng S, Valerius NH, Pedersen M, Hoiby N. Retrospective clinical study of hypersensitivity reactions to aztreonam and six other beta-lactam antibiotics in cystic fibrosis patients receiving multiple treatment courses. Rev Infect Dis 1991 13(Suppl 7) S608-11. 

Three of twenty-eight patients taking high-dose aztreonam (300 mg/kg/day) for cystic fibrosis developed mild and transient thrombocytopenia (9). 

Schaad UB, Wedgwood-Krucko J, Guenin K, Buehlmann U, Kraemer R. Antipseudomonal therapy in cystic fibrosis aztreonam and amikacin versus ceftazidime and amikacin admiuistered intravenously followed by oral ciprofloxacin. Eur J Clin Microbiol Infect Dis 1989 8(10) 858-65. 

Jensen T, Koch C, Pedersen SS, Hoiby N. Aztreonam for cystic fibrosis patients who are hypersensitive to other beta-lactams. Lancet 1987 l(8545) 1319-20. 

Moss RB, McClelland E, Williams RR, Hilman BC, Rubio T, Adkinson NF. Evaluation of the immunologic cross-reactivity of aztreonam in patients with cystic fibrosis who are allergic to penicillin and/or cephalosporin antibiotics. Rev Infect Dis 1991 13(Suppl 7) S598-607. 

Aronoff SC, Klinger JD. In vitro activities of aztreonam, piperacillin and ticarcillin combined with amikacin against amikacin-resistant Pseudomonas aeruginosa and P. cepacia isolates from children with cystic fibrosis. Antimicrob Agents Chemother 1984 25 279-280. 

Drug formulations In February 2010, a solution of aztreonam for inhalation, formulated with lysine, was approved by the US FDA for the treatment of respiratory symptoms in patients with cystic fibrosis and infected with Pseudomonas aeruginosa [75 ], a bacterium that has always been difficult to treat with antibiotics, especially when it grows in biofilm, as is the case in the airways. So far, no new types of adverse effects have been found [76 ]. A key problem will be the development of resistance to this new formulation [77 ]. 

Plosker GL. Aztreonam lysine for inhalation solution in cystic fibrosis. Drugs 2010 70(14) 1843-55. 

---