The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
This company-sponsored study is an one-arm, prospective, and, cohort-observational study in pediatrics (less than 15 years old) administered Ciproxan injection. All patients in the contracted institute should be enrolled into this study. Consequently 45 cases will be is planned to be enrolled in three-year period Target population is pediatrics with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa. The treatment should be performed based on the product label in Japan. The standard observation will be performed until the last date of the treatment.
Study Type
OBSERVATIONAL
Enrollment
48
Treatment parameters following the physician's decision based on the summary of product characteristics.
Unnamed facility
Multiple Locations, Japan
Number of musculoskeletal adverse events.
Time frame: Up to 12 months
Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)
Time frame: At week 6
Number of participants with adverse events as measure of safety and tolerability
Time frame: At week 4
Efficacy
Rated by physician with 3-grade scale
Time frame: Up to 2 weeks
Number of participants with adverse events based on abnormal laboratory measurements
Time frame: At week 4
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