Official Title: “A Prospective, Open-Label, Non-Randomized, Naturalistic, Long-Term Safety Surveillance, Observational Study of Ciprofloxacin (Either as Oral Suspension, Oral Tablets or Sequential IV - Oral Therapy or Purely IV Therapy) in the Treatment of Pediatric Patients With a Variety of 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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: Ciprofloxacin
  • Either as oral suspension, oral tablets or sequential 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
• Active Comparator: Comparator

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 Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on July 02, 2009

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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