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Special Drug Use Investigation of Ciproxan Injection in Pediatrics

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ClinicalTrials.gov Identifier: NCT02555059
Recruitment Status : Completed
First Posted : September 21, 2015
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax 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.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Ciproxan® Injection in Pediatrics
Actual Study Start Date : July 15, 2016
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 17, 2018


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.




Primary Outcome Measures :
  1. Number of musculoskeletal adverse events. [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555059


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02555059     History of Changes
Other Study ID Numbers: 18235
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Ciprofloxacin
Japan
Post-marketing surveillance
Additional relevant MeSH terms:
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Anthrax
Cystic Fibrosis
Cystitis
Pyelonephritis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Urinary Bladder Diseases
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors