Study design (if review, criteria of inclusion for studies)
Parallel design. Randomisation table used.
Participants
Once daily: n = 12 (8 male); age range 5.6 - 19.3 years. 22 participants with diagnosis of CF. Thrice daily: n = 10 (6 male); age range 7.4 - 17.2 years. Pulmonary exacerbation defined.
Interventions
14 days of treatment. Once-daily dosing (15 mg/kg/day) versus thrice-daily dosing (15 mg/kg/day) of tobramycin. Combination therapy with ceftazidime (200 mg/kg/day).
Variables improving (p < 0.05) in both groups A and B were, respectively: weight/height (+4% and +3.1%), plasma prealbumin (+66 and +63 mg/l), forced vital capacity (FVC) (+14% and +11%), forced expiratory volume in one second (+15% and +14%), and forced expiratory flow between 25% and 75% of FVC (+13% and +21%). Improvement was not significantly different between groups. Renal and cochlear indices remained within the normal range. Serum peak concentration of tobramycin on day 1 was 13.2 (7.1) mg/l in group A and 42.5 (11.2) mg/l in group B (p < 0.001); serum trough was 1.1 (0.8) mg/l in group A and 0.3 (0.2) mg/l in group B (p < 0.01). Tobramycin concentrations in sputum were two to three times higher in group B than group A.
Authors' conclusions
Once daily tobramycin combined with three injections of ceftazidime is safe and effective for the treatment of pseudomonas exacerbations in cystic fibrosis patients.