Retrospective Analysis to Characterize the Real World Use Patterns, Efficacy and Safety of Ceftazidime-avibactam in the Management of Gram Negative Infections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 189
- 试验地点
- 7
- 主要终点
- Number of Participants With Clinical Symptom Improvement at Day 3
研究概览
简要总结
The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India. Eligible patients would be adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice from 01 June 2019 to 01 April 2020. Data of 500 patients will be collected through the abstraction of hospital medical records (electronic) if available or through the individual patient medical record in case electronic records are not available.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •more than or equal to 18 years of age
- •Admitted to hospital with documented gram negative infection
- •Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management
排除标准
- •The patient is enrolled in any clinical trial of an investigational product
- •Age <18 years
- •Received Ceftazidime avibactam for less than 48 hours.
- •Patient with documented Acinetobacter infection.
- •Patient was a part of named access program or any other interventional study
研究组 & 干预措施
Cohort 1
Eligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice
干预措施: Ceftazidime-avibactam (Drug)
结局指标
主要结局
Number of Participants With Clinical Symptom Improvement at Day 3
时间窗: Day 3 after ceftazidime-avibactam initiation
The clinical symptom improvement was assessed as per the clinical judgement of the physician and reported as symptom improved and symptom worsened.
Number of Participants With Microbiological Success at Day 14 or End of Treatment
时间窗: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam
时间窗: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. All AEs that did not meet the criteria for "serious" were considered as non-serious. Adverse events with explicit attribution to any Pfizer drug that appeared in the reviewed information (defined per the participant population and study period specified in the protocol) were reported. Explicit attribution was not inferred by temporal relationship between drug administration and an AE, but was based on a causality assessed by a healthcare provider linking drug administration and AE.
Number of Participants With Treatment Success at Day 7
时间窗: Day 7 after ceftazidime-avibactam initiation
The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).
Number of Participants With Treatment Success at Day 14 or End of Treatment
时间窗: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).
Number of Participants With Microbiological Success at Day 7
时间窗: Day 7 after ceftazidime-avibactam initiation
Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).
次要结局
- Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used(Baseline (before initiation of initial antibiotic therapy))
- Number of Participants With History of Antibiotic Exposure(90 days prior to current hospital admission)
- Number of Participants According to Identified Gram Negative Organisms(Baseline (before the initiation of initial antibiotic therapy))
- Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam(Baseline (before the initiation of initial antibiotic therapy))
- Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used(Baseline (before the initiation of initial antibiotic therapy))
- Duration of Administration of Ceftazidime - Avibactam(Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier)
- Total Duration of Therapy of Ceftazidime-Avibactam(Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier)
- Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam(Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier)
- Dose of Ceftazidime - Avibactam(Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier)
- Number of Participants According to Frequency of Administration(Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier)
- Duration of Hospital Stay(Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days))
- Duration of Stay in Intensive Care Unit (ICU)(Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days))
- Number of Participants With Recurrence of Infection(Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days))
- Number of Participants According to Healthcare Resource Utilization(Up to 30 days post treatment completion with ceftazidime-avibactam death or discharge; whichever was first (Up to maximum of 49 days))