Special Drug Use Investigation of Ciproxan Injection in Pediatrics

Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax Clinical Trial

Official title:

Special Drug Use Investigation of Ciproxan® Injection in Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555059
• Other study ID #: 18235
• Status: Completed
• Start date: July 15, 2016
• Est. completion date: June 13, 2019

Study information

• Verified date: February 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 13, 2019
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anthrax
• Cystic Fibrosis
• Cystitis
• Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax
• Pyelonephritis

Intervention

Drug:
• Cipro (Ciprofloxacin, BAYQ3939)
Treatment parameters following the physician's decision based on the summary of product characteristics.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of musculoskeletal adverse events.		Up to 12 months
Secondary	Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)		At week 6
Secondary	Number of participants with adverse events as measure of safety and tolerability		At week 4
Secondary	Efficacy	Rated by physician with 3-grade scale	Up to 2 weeks
Secondary	Number of participants with adverse events based on abnormal laboratory measurements		At week 4

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