Study design (if review, criteria of inclusion for studies)
1) open-label, uncontrolled trial 2) open-label, randomized, controlled study 3) another study
Participants
1) 16 CF patients. 2) 25 CF patients were entered in the controlled trial with 12 patients in each treatment group being evaluable. The groups were comparable based on admitting demographic and disease characteristics
Interventions
1) 25 courses of ciprofloxacin 2) ciprofloxacin or intravenous tobramycin and azlocillin. 3) two years of clinical use
Outcome measures
1) Efficacy and safety (short-term clinical scores, white blood cell counts, Pseudomonas aeruginosa counts in sputum, pulmonary function tests, and standard serum chemistries and urinalysis that were performed before therapy, weekly during therapy, at the end of therapy, and at a seven-day follow-up visit after therapy. 2) efficacy and tolerance 3) antibiotic susceptibility of P. aeruginosa isolated from cystic fibrosis patients during more than two years of clinical use was determined.
Main results
In the uncontrolled trial, ciprofloxacin therapy was associated with clinical improvement in most cases with changes in short-term clinical score and forced expiratory volume in one second being statistically significant (p less than 0.05). in the controlled trial no differences in therapeutic response or side effects were noted between the two treatments (p greater than 0.5). Bacterial susceptibility to ciprofloxacin has remained relatively stable over time.
Authors' conclusions
Based on these results as well as those from similar evaluations, ciprofloxacin appears to be efficacious in the treatment of acute pulmonary exacerbations in adults with cystic fibrosis, producing responses similar to those observed with standard intravenous antibiotic therapy.