Special Drug Use Investigation of Ciproxan Injection in Pediatrics

Special Drug Use Investigation of Ciproxan® Injection in Pediatrics

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

Study Overview

• Status: Completed
• Conditions: Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax
• Intervention / Treatment: Drug: Cipro (Ciprofloxacin, BAYQ3939)

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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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, are enrolled after the decision for treatment with Ciproxan injection has been made by the investigator.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BAYQ3939; Pediatrics patients treated with Ciproxan injection in daily clinical practice.	Drug: Cipro (Ciprofloxacin, BAYQ3939); Treatment parameters following the physician's decision based on the summary of product characteristics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2016
• Primary Completion (Actual): December 17, 2018
• Study Completion (Actual): June 13, 2019

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Japan; Post-marketing surveillance; Ciprofloxacin
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Diseases; Lung Diseases; Kidney Diseases; Urologic Diseases; Urinary Bladder Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pancreatic Diseases; Nephritis; Nephritis, Interstitial; Pyelitis; Bacillaceae Infections; Cystitis; Cystic Fibrosis; Pyelonephritis; Anthrax; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 18235

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No