Special Drug Use Investigation of Ciproxan Injection in Pediatrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-15

Study Completion Date

2019-06-13

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.

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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.

Conditions

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Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BAYQ3939

Pediatrics patients treated with Ciproxan injection in daily clinical practice.

Cipro (Ciprofloxacin, BAYQ3939)

Intervention Type DRUG

Treatment parameters following the physician's decision based on the summary of product characteristics.

Interventions

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Cipro (Ciprofloxacin, BAYQ3939)

Treatment parameters following the physician's decision based on the summary of product characteristics.

Intervention Type DRUG

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.