Treatment of early Pseudomonas aeruginosa infection in patients with cystic fibrosis: the ELITE trial.
BACKGROUND
Antibiotic therapy for early Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) is effective, but the optimal therapeutic regimen and duration for early treatment remains unclear. The EarLy Inhaled Tobramycin for Eradication (ELITE) study was designed to assess the efficacy and safety of two regimens (28 and 56 days) of tobramycin inhalation solution (TIS) 300 mg/5 ml twice daily for the treatment of early onset P aeruginosa infection in patients with CF.


METHODS
In this open-label randomised multicentre study, patients with CF (aged > or = 6 months) with early P aeruginosa infection were treated for 28 days with TIS twice daily administered by the PARI LC PLUS (PARI GmbH, Starnberg, Germany) jet nebuliser. After 28 days, patients were randomised 1:1 to either stop TIS (n=45) or to receive a further 28 days of TIS (n=43). The primary endpoint was the median time to recurrence of P aeruginosa (any strain). Secondary endpoints included the proportion of patients free of P aeruginosa infection 1 month after cessation of therapy and safety assessments.


RESULTS
The median time to recurrence of P aeruginosa (any strain) was similar between the two groups. In total, 93% and 92% of the patients were free of P aeruginosa infection 1 month after the end of treatment and 66% and 69% remained free at the final visit in the 28-day and 56-day groups, respectively. TIS was well tolerated.


CONCLUSIONS
Treatment with TIS for 28 days is an effective and well tolerated therapy for early P aeruginosa infection in patients with CF.


BACKGROUND
NCT00391976.
Ratjen
Felix
F
Division of Respiratory Medicine, Department of Pediatrics, University of Toronto, Hospital for Sick Children, 555 University Avenue, Toronto M5G 1X8, Ontario, Canada. felix.ratjen@sickkids.ca
Munck
Anne
A
Kho
Pearl
P
Angyalosi
Gerhild
G
D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000150:complications*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009894:Opportunistic Infections / Q000150:complications / Q000188:drug therapy*; D011552:Pseudomonas Infections / Q000150:complications / Q000188:drug therapy*; D011550:Pseudomonas aeruginosa; D014031:Tobramycin / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D014031:Tobramycin