Review Article

Treatment of Pseudomonas and Staphylococcus Bronchopulmonary Infection in Patients with Cystic Fibrosis

Table 2

Summary of TIS/TSI trials.

AuthorStudy designSubjectsDose usedOutcomesMain results

Chuchalin et al. [7]Multicenter, RCT .
Age = Adults.
Inclusion criteria: chronic P. aeruginosa infection
Tobramycin 300 mg for 24 weeks Percent change in FEV1, FVC, and FEF25–75%, pulmonary exacerbations, use of parenteral antibiotics, and rate of hospitalizationsSignificantly improved FEV1, FVC, and FEF25–75%. The % of patients hospitalized as well as the need for parenteral antibiotics was significantly lower

Lenoir et al. [8]RCT .
Age = 6–30 years.
Inclusion criteria: chronic P. aeruginosa infection
Tobramycin 300 mg BID for 4 weeks Percent change in FEV1, FVC, and FEF25–75%Significantly improved FEV1, FVC, and FEF25–75%

MacLusky et al. [9]RCT .
Age = 7–24 years.
Inclusion criteria: chronic P. aeruginosa infection
Tobramycin 80 mg BID for 33 months Lung function (FEV1 and FVC), clinical scores, and exacerbationsThe treatment group showed no change, while the control group had a significant decline in both pulmonary function and clinical status

Murphy et al. [10]Multicenter, RCT .
Age = 6–15 years.
Inclusion criteria: CF with mild lung disease
Tobramycin 300 mg BID, alternating 4-weekly cycles for 56 weeksLung function, hospitalisation, and antibiotic useSignificant reductions in hospitalizations, antibiotic use, and a trend towards improvement in FEF25–75%

Ramsey et al. [11]Multicenter, Crossover study .
Age = ≥6 years.
Inclusion criteria: chronic P. aeruginosa infection and FVC >40%
Tobramycin 600 mg TID for 4 weeks then crossover for two 28-day periodsLung function (FEV1, FVC, and FEF25–75%), exacerbations of infection and antibiotic useIncrease in the % change in FEV1, FVC, and FEF25–75%. Fewer exacerbations of infection and antibiotic use

Ramsey et al. [12]Multicenter, RCT .
Age = ≥6 years.
Inclusion criteria: chronic P. aeruginosa infection, FEV1 ≥25% and ≤75% predicted
Tobramycin 300 mg BID in three on-off cycles for a total of 24 weeksLung function (FEV1 and FVC), exacerbations (hospitalization or IV antibiotics)Increase in the % change in FEV1 and FVC. Fewer hospitalizations and antibiotic use

Moss [13]Multicenter, RCT .
Age = 13–17 years.
Inclusion criteria: chronic P. aeruginosa with mild-to-moderate lung disease (FEV1 ≥25% and ≤75% predicted)
Tobramycin 300 mg in three 28-day cyclesPulmonary function, incidence of hospitalization, and IV antibiotic useIncrease in the % change in FEV1. The average number of hospitalizations and IV antibiotic courses did not increase over time

Stelmach et al. [14]Observational study .
Age = 6–18 years.
Inclusion criteria: chronic P. aeruginosa infection with FEV1 ≥25% and ≤75% predicted
Tobramycin 300 mg in two 28-day cyclesPulmonary function, clinical status over 2-year periodSignificant decline in lung function, clinical improvement

Galeva et al. [15]RCT .
Age = 6–21 years.
Inclusion criteria: chronic P. aeruginosa infection and FEV1 ≥25% and ≤80% predicted
Tobramycin BID for one treatment cycle (18.5 days on drug, 28 days off drug)Change in FEV1%, quality of lifeChange in FEV1%, quality of life

Konstan et al. [16]RCT .
Age = 6–21 years.
Inclusion criteria: chronic P. aeruginosa infection and FEV1 ≥25% and ≤80% predicted
Tobramycin 112 mg BID for a total of three cycles (each cycle, 28 days on and 28 days off drug)Change in FEV1%Increase in FEV1% along with decrease in the number of hospitalizations and antibiotic use