Trial Condition(s):
Cystitis / Pyelonephritis / Cystic fibrosis / Anthrax
Special Drug Use Investigation of Ciproxan injection in pediatrics
Bayer Identifier:
18235
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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 Summary
Enrollment Goal
48
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
1
Primary Outcome
- Number of musculoskeletal adverse events.Timeframe: Up to 12 months
Secondary Outcome
- Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)Timeframe: At week 6
- Number of participants with adverse events as measure of safety and tolerabilityTimeframe: At week 4
- EfficacyRated by physician with 3-grade scaleTimeframe: Up to 2 weeks
- Number of participants with adverse events based on abnormal laboratory measurementsTimeframe: At week 4
Additional Information
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