Special Drug Use Investigation of Ciproxan Injection in Pediatrics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Special Drug Use Investigation of Ciproxan® Injection in Pediatrics

Conditions
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Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax

Intervention / Treatment
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* Drug: Cipro (Ciprofloxacin, BAYQ3939)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAYQ3939<br>Pediatrics patients treated with Ciproxan injection in daily clinical practice. | Drug: Cipro (Ciprofloxacin, BAYQ3939)<br>* Treatment parameters following the physician's decision based on the summary of product characteristics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of musculoskeletal adverse events. |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Rated by physician with 3-grade scale | Up to 2 weeks | 
| Number of participants with adverse events based on abnormal laboratory measurements |  | At week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ciprofloxacin, Japan, Post-marketing surveillance