Retrospective Chart Review to Evaluate the Safety Profile of Ceftobiprole in Patients With Impaired Hepatic or Renal Function or Immunosuppression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 428
- 试验地点
- 18
- 主要终点
- Estimation of the proportion and relative frequency of treatment-emergent AEs and AEs of special interest
研究概览
简要总结
In this observational study, data from patients treated with the antibiotic ceftobiprole in the past will be collected. The sponsor of the study is Correvio International Sárl, based in Switzerland. Correvio has committed to the health authorities to obtain further information on possible side effects especially in patients suffering from impaired liver or renal function or immune system deficiency and compare these effects to the ones observed in patients without these health problems. Patient data are collected from historic patient charts, patients will not be treated for the purpose of this data collection. All efforts are being made to capture the data of all patients who meet the inclusion criteria and have received at least one dose of ceftobiprole since this drug was first prescribed at the site.
详细描述
Rationale and background:
Ceftobiprole is a beta-lactam antibiotic with bactericidal activity against a broad spectrum of Gram-positive and Gram-negative bacteria, that was developed to treat patients with pneumonia both in a hospital or community setting. Clinical trials were conducted in adult immune-competent patients with normal or mild to moderate renal or hepatic function impairment. The clinical trial program completed to date has excluded patients with immune suppression and significant organ function impairment (hepatic or renal). The safety profile of ceftobiprole in these patient groups was recognized during the marketing authorization procedure as important missing information and the applicant committed to conduct a post authorization safety study.
A randomized Phase 3 study in the indication of acute bacterial skin and skin structure infections (ABSSSIs) is completed (NCT03137173), and a randomized Phase 3 study in the indication of S. aureus bacteremia is ongoing (NCT03138733). This retrospective chart review is conducted to further evaluate the safety profile of ceftobiprole in patient populations with specific risk factors.
Research question:
To estimate the proportion and the relative frequency of treatment-emergent adverse events (AEs) and adverse event of special interest will be assessed in patients treated with ceftobiprole and who have at least one of the following conditions:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
With medical condition of interest
Participants treated with ceftobiprole with at least one of the following conditions:
- Renal Insufficiency
- Hepatic Insufficiency
- Immunosuppression
干预措施: Ceftobiprole medocaril (Drug)
Without medical condition of interest
Patients treated with ceftobiprole without any of the following conditions:
- Renal Insufficiency
- Hepatic Insufficiency
- Immunosuppression
干预措施: Ceftobiprole medocaril (Drug)
结局指标
主要结局
Estimation of the proportion and relative frequency of treatment-emergent AEs and AEs of special interest
时间窗: during and until 28 days after completion of ceftobiprole therapy
Assessment of hyponatraemia
时间窗: during and until 28 days after completion of ceftobiprole therapy
Assessement of Pseudomembranous colitis / Clostridium difficile colitis
时间窗: during and until 28 days after completion of ceftobiprole therapy
Assessment of convulsions
时间窗: during and until 28 days after completion of ceftobiprole therapy
Assessment of hepatobiliary disorders
时间窗: during and until 28 days after completion of ceftobiprole therapy
Assessment of renal toxicity (including potential interactions with nephrotoxic drugs)
时间窗: during and until 28 days after completion of ceftobiprole therapy
Assessment of Coombs test (DAT) positivity + clinical evidence of haemolysis
时间窗: during and until 28 days after completion of ceftobiprole therapy
Assessment of hypersensitivity reactions, including anaphylactic reactions
时间窗: during and until 28 days after completion of ceftobiprole therapy
次要结局
- Adverse events by indication(during and until 28 days after completion of ceftobiprole therapy)
- Treatment duration in days(During ceftobiprole therapy)
- Treatment dosage(During ceftobiprole therapy)