Special Drug Use Investigation of Ciproxan Injection in Pediatrics

Bayer

Status: Completed

Conditions: Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax

Treatments: Drug: Cipro (Ciprofloxacin, BAYQ3939)

Study type: Observational

Funder types: Industry

Identifiers

NCT02555059

18235

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

BAYQ3939

Description:

Pediatrics patients treated with Ciproxan injection in daily clinical practice.

Treatment:

Drug: Cipro (Ciprofloxacin, BAYQ3939)