BAY 0 9867 Cipro Pediatric Use Study (QUIP)

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.

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.