BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Official Title: “A Prospective, Open-label, Non-randomized, Naturalistic, Long-term Safety Surveillance, Observational Study of Either Ciprofloxacin (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) or a Non-quinolone Antibiotic (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) in the Treatment of Pediatric Patients With Infectious Diagnoses”

Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such musculoskeletal conditions is in the general pediatric population.

This study is classified as "interventional" due to study-specific medical examinations and interventions. Regarding the study drug intake, routine administration is observed only, there is no intervention in study drug administration.

Intervention(s) in this Clinical Trial

• Drug: Ciprofloxacin
  • Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
• Drug: Non-quinolone antibiotic
  • Common used dose and route

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Ciprofloxacin
  • Subjects receiving Ciprofloxacin (group followed-up for 5 years)
• Active Comparator: Non-quinolone antibiotic
  • Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)

Primary Measures

• Incidence of Arthropathy (Cumulative)
  • Time Frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
    Safety Issue?: Yes
• Incidence of Nervous System Events (Cumulative)
  • Time Frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
    Safety Issue?: Yes

Inclusion Criteria:

• Patient is >/= 2 months of age through 16 years of age
• A parent/caregiver must sign an informed consent
• Patient must provide assent, as appropriate based on local institutional review board guidelines

Exclusion Criteria:

• Patients presenting with the following conditions:
• exacerbations of cystic fibrosis (CF)
• meningitis
• Brain abscess
• bacterial endocarditis,
• Bone and joint infections
• having any of the following conditions but lacking a personal history may be admitted to the trial:
• Arthritis
• Juvenile rheumatoid arthritis (JRA)
• Rheumatoid arthritis (RA)
• Systemic lupus erythematosis (SLE)
• History of rheumatic fever
• Psoriasis
• Inflammatory bowel disease
• Osteoarthritis (OA)
• Known underlying rheumatological disease, joint problems known to be associated with arthropathy.
• Patients with any pre-treatment baseline musculoskeletal exam abnormalities
• Known risk of experiencing seizures, a history of any convulsive disorders
• Requiring any concomitant therapeutic course of systemic antibacterial agent
• Participation in any industry-sponsored clinical drug development study within one month prior to this study
• Known significant liver impairment (ALAT/ASAT and/or baseline bilirubin > 3 times upper limit of normal)
• Known significant renal insufficiency (calculated creatinine clearance of < 30 ml/min/1.73 m²)
• Are pregnant or lactating, or are sexually active and using unreliable contraception.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Months

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00761462

Study ID Number: 100201

ClinicalTrials.gov Identifier: NCT00761462

Health Authority: United States: Food and Drug Administration

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