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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,029
- 主要终点
- Incidence of Arthropathy (Cumulative)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Ciprofloxacin
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
干预措施: Ciprofloxacin (Drug)
Non-quinolone antibiotic
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
干预措施: Non-quinolone antibiotic (Drug)
结局指标
主要结局
Incidence of Arthropathy (Cumulative)
时间窗: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.
Incidence of Nervous System Events (Cumulative)
时间窗: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.
次要结局
未报告次要终点