Study design (if review, criteria of inclusion for studies)
randomized multicenter study
Participants
29 patients with cystic fibrosis treated for pulmonary infections associated with Pseudomonas aeruginosa. Patients ranged in age from 12 to 30 years. Their infections were classified as mild (6), moderate (16), or severe (7). Non-randomized patients (n=46)
Interventions
14 patients received cefsulodin, 14 patients were treated with tobramycin, and 1 patient received ticarcillin. Non-randomized patients were treated with cefsulodin.
Significant clinical improvement was noted in the majority of patients in both groups. Adverse effects and development of laboratory abnormalities were uncommon in both groups. P. aeruginosa was not permanently eradicated from the sputum of any of the patients. Results of the nonrandomized portion of this study were similar to those for the randomized group.
Authors' conclusions
Resistance as measured by disk susceptibility testing may have developed during and immediately after therapy in the cefsulodin group but not in those treated with reference agents. However, this did not appear to affect the clinical outcome. Cefsulodin was shown to be as clinically effective as the reference agents in the treatment of lower respiratory tract infections due to Pseudomonas aeruginosa in patients with cystic fibrosis.