Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
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.
Age
0–16
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | BAY 0 9867 Cipro Pediatric Use Study (QUIP)
