An observational study in Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax, sponsored by Bayer. Completed at 1 site in Japan. Open to participants aged Up to 14 Years. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Bayer · Observational
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's enrollment of 48 is below the median of 216 across 15 observational studies indexed under Cystitis.
Browse Cystitis studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
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Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa, are enrolled after the decision for treatment with Ciproxan injection has been made by the investigator.
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Exclusion Criteria:
Pediatrics patients treated with Ciproxan injection in daily clinical practice.
Drug: Cipro (Ciprofloxacin, BAYQ3939)
Treatment parameters following the physician's decision based on the summary of product characteristics.
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
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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