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Completed

NCT Number: NCT02555059

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.

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Key information

Conditions

Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Cystitis Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gram-Positive Bacterial Infections Infant, Newborn, Diseases Infections Kidney Diseases Lung Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pancreatic Diseases Pyelitis Pyelonephritis Respiratory Tract Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cipro (Ciprofloxacin, BAYQ3939)

Drug

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

Primary outcomes

  1. Number of musculoskeletal adverse events.

    Time frame: Up to 12 months

Secondary outcomes

  1. Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)

    Time frame: At week 6

  2. Number of participants with adverse events as measure of safety and tolerability

    Time frame: At week 4

  3. Efficacy

    Time frame: Up to 2 weeks

    Rated by physician with 3-grade scale

  4. Number of participants with adverse events based on abnormal laboratory measurements

    Time frame: At week 4

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Special Drug Use Investigation of Ciproxan® Injection in Pediatrics

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 21, 2015
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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