check_circleStudy Completed

Cystitis / Pyelonephritis / Cystic fibrosis / Anthrax

Bayer Identifier:

18235

ClinicalTrials.gov Identifier:

NCT02555059

EudraCT Number:

Not Available

EU CT Number:

Not Available
Special Drug Use Investigation of Ciproxan injection in pediatrics

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

NaN - 14 Years
  • - 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.
  • - N/A

Trial summary

Enrollment Goal
48
Trial Dates
July 2016 - June 2019
Phase
N/A
Could I Receive a placebo
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Number of musculoskeletal adverse events.
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No

Secondary Outcome

  • Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)
    date_rangeTime Frame:
    At week 6
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    Safety Issue:
    No
  • Number of participants with adverse events as measure of safety and tolerability
    date_rangeTime Frame:
    At week 4
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    Safety Issue:
    Yes
  • Efficacy
    Rated by physician with 3-grade scale
    date_rangeTime Frame:
    Up to 2 weeks
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    Safety Issue:
    No
  • Number of participants with adverse events based on abnormal laboratory measurements
    date_rangeTime Frame:
    At week 4
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    Safety Issue:
    Yes

Trial design

Special Drug Use Investigation of Ciproxan® injection in pediatrics
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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