Special Drug Use Investigation of Ciproxan Injection in Pediatrics

NCT02555059 | Completed

• 1 other identifier: 18235
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax

Keywords

Ciprofloxacin; Japan; Post-marketing surveillance

Outcome Measures

Primary Outcomes (1)

• Number of musculoskeletal adverse events.

  Up to 12 months

Secondary Outcomes (4)

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

  At week 6

• Number of participants with adverse events as measure of safety and tolerability

  At week 4

• Efficacy

  Up to 2 weeks

• Number of participants with adverse events based on abnormal laboratory measurements

  At week 4

Study Arms (1)

BAYQ3939

Pediatrics patients treated with Ciproxan injection in daily clinical practice.

Drug: Cipro (Ciprofloxacin, BAYQ3939)

Interventions

Cipro (Ciprofloxacin, BAYQ3939) DRUG

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

BAYQ3939

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Links

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MeSH Terms

Conditions

Cystitis; Pyelonephritis; Cystic Fibrosis; Anthrax

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 21, 2015
• Study Start: July 15, 2016
• Primary Completion: December 17, 2018
• Study Completion: June 13, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

JP (1)