Ｃｉｐｒｏｆｌｏｘａｃｉｎ注射薬の後期第ＩＩ相臨床試験　　重症および難治性感染症における臨床的検討

DOI 被引用文献7件 参考文献26件

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  • Phase IIb study of ciprofloxacin I.V. Clinical study in patients with severe and/or refractory infections.
  • Clinical study in patients with severe and/or refractory infections
  • 重症および難治性感染症における臨床的検討

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The clinical efficacy, safety and usefulness of injectable ciprofloxacin for patients with severe and/or refractory infections were evaluated as a phase Ilb study. Patients were intravenously treated with 200 mg b. i. d., t. i. d. or 300 mg b. i. d. for 14 days at the longest. The following results were obtaind.<BR>1. Among the 174 cases infused, 153 were evaluated for clinical efficacy, 163 for safety and 152 for usefulness.<BR>2. In the 153 cases available for the efficacy evaluation, 72.5% were more than 60 years old, 44.9% had far-advanced infectious symptoms and findings, 74.5% had unacceptable underlying diseases and 54.9% were not evaluable due to having recently been treated with other antimicrobial agents.<BR>3. Clinical efficacy was 70.6% in the total of 153 cases, 72.1% in 68 cases with respiratory infections, 86.0% in 50 cases with surgical infections, including 6 cases of bacterial sepsis, and 45.7% in 35 cases with complicated or severe urological infections. Dose dependent efficacy was seen in the group with respiratory infections, that is 66.7% in cases treated with a 400 mg daily dose and 75.6% in the 600 mg group. No dose dependency was recognized in the groups with surgical infections and urological infections.<BR>4. One hundred sixty six strains, including those divided from the cases with polymicrobial infections, were determined as causative pathogens. Most were among the 18 strains of MRSA, 11 strains of Staphylococcus aureus, 18 strains of Enterococcus faecalis, 40 strains of Pseudomonas aeruginosa, 11 strains of other Non-fermentatable gram negative rods (NF-GNR) and 10 strains of anaerobes. The bacterial elimination ratio was 60.8%., the percentages were 50.0% MRSA, 45.5% other S. aureus, 38.9% E. faecalis, 40.0% P.aeruginosa, 72.7% NF-GNR and 80.0% anaerobes. Elimination of other community acquired pathogens, such as Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae and Haemophilus influenzae was 84.2%.<BR>5. Side effects were noted 11 cases (6.6%). Six events of temporary pain at the injection site, 4 of gastrointestinal symptoms, were observed. Temporary cramping was seen in patients with bacterial meningitis. Neither severe side effects nor sequela occurred. Abnormalities in laboratory findings were noted in 17 cases, mostly slight elevation of GOT (9 events) and GPT (9 events). Others included slightly abnormal RBC, Hb, Ht, AL-P, γ-GTP, LDH, TP, BUN and S-Cr. No dose dependency was found between the 400 mg and the 600 mg group. The safety-ability, in terms of “overall safety”, was 82.8% in 163 cases evaluated.<BR>6. From the above findings, the 600 mg daily dose of injectable ciprofloxacin is an acceptable treatment for patients with severe and/or refractory infections in the respiratory and surgical fields.

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