BAY 0 9867 Cipro Pediatric Use Study (QUIP)

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ciprofloxacin

Criteria

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.