Special Drug Use Investigation of Ciproxan Injection in Pediatrics

Completed

• Conditions: Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax
• Interventions: Drug: Cipro (Ciprofloxacin, BAYQ3939)

• Registration Number: NCT02555059
• Lead Sponsor: Bayer

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.

Study Timeline

• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-21
• Study Start: 2016-07-15
• Primary Completion: 2018-12-17
• Study Completion: 2019-06-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAYQ3939	Cipro (Ciprofloxacin, BAYQ3939)	Pediatrics patients treated with Ciproxan injection in daily clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of musculoskeletal adverse events.	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
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