Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study

Abstract

AZLI was effective and well tolerated in eradicating Pa from newly infected pediatric patients with CF. These eradication rates are consistent with success rates reported in the literature for various antibiotic regimens, including other inhaled antibiotics studied for eradication. ClinicalTrials.gov: NCT01375049.

Inhaled antibiotics: dry or wet?

“…In addition, early treatment using inhaled nebulised tobramycin against P. aeruginosa given at the time of first isolation prevents chronic infection in about twothirds of patients [7,13,14]. Similar efficacy was recently observed in a study with nebulised aztreonam lysine [15]. Furthermore, treatment with nebulised aztreonam lysine has been shown to be effective in delaying the need for inhaled or intravenous anti-P. aeruginosa antibiotics for pulmonary exacerbations in CF patients, and in an improved quality of life [16].…”

“…For antibiotic treatment of newly acquired P. aeruginosa, nebulised antibiotics are considered the standard of treatment [9]. For patients without elevated P. aeruginosa antibodies, 1 month of nebulised TIS or AZLI has been shown to be effective in eradicating P. aeruginosa in up to ,90% of patients [7,15]. However, positive P. aeruginosa antibodies or history of recurrent P. aeruginosa infection reduced the chance of successful eradication to 36-48% of patients.…”

“…Taking into account the differences that can exist in the aerosol distribution pattern between TIS and TIP, it cannot automatically be assumed that TIP is equally effective as TIS in eradicating P. aeruginosa. Hence, until eradication studies with TIP or Colobreathe have been undertaken, the treatment options for first P. aeruginosa acquisition is TIS, AZLI or nebulised colistin [7,15].…”

Consenso español para la prevención y el tratamiento de la infección bronquial por Pseudomonas aeruginosa en el paciente con fibrosis quística

“…Posible aumento del recuento bacteriano En pacientes sin estudio microbiológico puede utilizarse como criterio diagnóstico el aumento de anticuerpos en 2 muestras de sangre sucesivas menos de 18 años, mostró que el 89,1% de los pacientes negativizó P. aeruginosa al final del tratamiento y el 75,2 y el 58,2% permanecieron sin P. aeruginosa a los 28 días y a los 6 meses, respectivamente, de su finalización 87 .…”

Cystic Fibrosis Papers of the Year, 2013-2014

“…The first was to assess its effectiveness at eradicating new Pseudomonas aeruginosa (measured by ''first ever'' isolate or first after two years of negative sputum samples with at least two samples collected per year) [9]. 58.2% (n=46) patients satisfied the primary endpoint of percentage of patients negative across the whole post-treatment study period (28 weeks).…”