Special Drug Use Investigation of Ciproxan Injection in Pediatrics

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02555059
• Date of registration: 18/09/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Special Drug Use Investigation of Ciproxan Injection in Pediatrics
• Scientific title: Special Drug Use Investigation of Ciproxan® Injection in Pediatrics
• Date of first enrolment: July 15, 2016
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02555059
• Study type: Observational

Countries of recruitment

Japan

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 14 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax

Intervention(s)

Drug: Cipro (Ciprofloxacin, BAYQ3939)

Primary Outcome(s)

Number of musculoskeletal adverse events. [Time Frame: Up to 12 months]

Secondary Outcome(s)

Efficacy [Time Frame: Up to 2 weeks]

Number of participants with adverse events as measure of safety and tolerability [Time Frame: At week 4]

Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N) [Time Frame: At week 6]

Number of participants with adverse events based on abnormal laboratory measurements [Time Frame: At week 4]

Secondary ID(s)

18235

Source(s) of Monetary Support

Please refer to primary and secondary sponsors