Comparison of the safety and efficacy of intravenous ciprofloxacin and intravenous ceftazidime in the treatment of selected infections.
(Clinical Trial;Journal Article)
A study was conducted to determine the comparative safety and efficacy of intravenous ciprofloxacin with that of intravenous ceftazidime in the treatment of selected infections. Male and female inpatients 18 years or older had bacterial infections of the blood, skin or skin/structure, intra-abdominal region, lower respiratory tract, or urinary tract (considered complicated) caused by organisms susceptible to both ciprofloxacin and ceftazidime. Patients were randomly assigned to receive either ciprofloxacin 200 mg intravenously every 12 hours or ceftazidime 0.5 to 2 g intravenously every eight to 12 hours. Clinical evaluations were performed daily during therapy and within five to nine days after therapy was complete. For patients with urinary tract infection, urine for culture was obtained during (Day 3 or 4) and after (five to nine days and three to five weeks) therapy. A total of 86 patients were enrolled into the study. Forty-three received ciprofloxacin and 43 received ceftazidime. There were 22 evaluable patients in the ciprofloxacin group with 24 infection sites: skin/skin structure (eight), respiratory tract (nine), blood (two), urinary tract (five). In the ceftazidime group, there were 26 evaluable patients with 29 infection sites: skin/skin structure (15), respiratory tract (nine), blood (three), and urinary tract (two). The mean duration of therapy with ciprofloxacin and ceftazidime was 7.5 days (range, four to 28 days) and 8.4 days (range, three to 25 days), respectively. Bacteriologic eradication of the causative organisms occurred at 17 infection sites (70.8 percent) in the ciprofloxacin-treated patients and 21 infection sites (72.4 percent) in the ceftazidime group. Clinically, resolution or improvement in signs/symptoms was demonstrated in 22 patients (91.7 percent) in the ciprofloxacin group and 26 patients (89.7 percent) in the ceftazidime group. Bacteriologic response (by organism) and overall response were comparable in both groups. All enrolled patients were evaluated for determination of safety. Adverse events considered possibly or probably related to the study drugs were reported in 16 of 43 patients (37.2 percent) in the ciprofloxacin group and four of 43 patients (9.3 percent) in the ceftazidime group. Ciprofloxacin and ceftazidime were equally efficacious in the treatment of selected infections, but ciprofloxacin was associated with a higher incidence of adverse reactions probably or possibly related to drug administration. Further studies with larger sample sizes in selected patient populations will be required to identify differences in efficacy among the two antibiotics.
Gallis, HA; Brennan, RO; Goodwin, SD; Swinney, V; Rumbaugh, MM; Drew, RH
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