Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax
Conditions
Keywords
Ciprofloxacin, Japan, Post-marketing surveillance
Brief summary
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
Detailed description
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.
Interventions
Treatment parameters following the physician's decision based on the summary of product characteristics.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Patients for whom the decision to initiate treatment with Ciproxan injection was made as per investigator's routine treatment practice.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of musculoskeletal adverse events. | Up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N) | At week 6 | — |
| Number of participants with adverse events as measure of safety and tolerability | At week 4 | — |
| Efficacy | Up to 2 weeks | Rated by physician with 3-grade scale |
| Number of participants with adverse events based on abnormal laboratory measurements | At week 4 | — |
Countries
Japan
Outcome results
None listed