Safety of Inhaled Tobramycin for Pseudomonas Eradication in People With Cystic Fibrosis Less Than 1 Year of Age.

BACKGROUND

Inhaled tobramycin solution is recommended for eradication treatment of Pseudomonas aeruginosa (PA) infections in people with cystic fibrosis (PwCF). However, there is limited information on the safety of inhaled tobramycin in PwCF less than 1 year old and no studies primarily analyzing the safety of the 300 mg inhaled solution. The objective of this study was to compare the incidence of adverse drug events (ADE) of inhaled tobramycin in PwCF less than 1 year old to PwCF ages 1 year to 18 years old.

METHODS

This retrospective analysis evaluated the incidence of inhaled tobramycin ADEs in PwCF ages 14 days to 18 years with CF between January 01, 2008 to January 01, 2022. PwCF less than 1 year of age (infant group) were matched based on genotype in a 1:3 ratio with a PwCF at least a year old to 18 year-old (children group).

RESULTS

Forty-eight patients were included (infant group: 12, children group: 36). Median (IQR) age was 0.48 years (0.2-0.7) and 4.7 years (2.3-10) in infant group and children group respectively (p < 0.05). There were 5 (41.7%) ADE in the infant group and 3 (8.3%) in the children group (p = 0.016). When cough was removed there was no significant difference between the two groups [2 (16.7%) vs. 1 (2.7%), p = 0.15]. There was no difference in treatment failure [3 (25%) vs. 7 (19.4%), p = 0.68].

CONCLUSIONS

This study found a higher incidence of inhaled tobramycin ADE in infants compared to children. These results show a low risk of ADE outside of cough, indicating that inhaled tobramycin may be safely used in this age group.