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

Bayer HealthCare AG0 个研究点目标入组 900 人开始时间: 2015年1月12日最近更新: 2015年1月19日

试验速览

暂无简介。

•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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 900
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

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