A Single-arm, Open-label, Prospective, Observational Study to Assess the Safety of Sulbactam-durlobactam, Including the Risk of Hypersensitivity Reactions (Including Anaphylaxis) in Participants With Acinetobacter Baumannii-calcoaceticus Complex Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Incidence of maximum severity level of AESIs
研究概览
简要总结
The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including anaphylaxis) in participants with Acinetobacter baumannii-calcoaceticus complex infection. Participants will be followed for approximately 28 days in order to collect safety and reaction data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Participant is ≥18 years old at the time of written informed consent and is hospitalized.
- •Participant has provided the written informed consent. If a participant is unable to provide written informed consent due to their medical condition, the participant's legally authorized representative may consent on behalf of the participant, or the decision can be made according to the procedure permitted by local law and institutional standard operating procedures (SOPs).
- •Participant has a proven or strongly suspected diagnosis of an infection caused by susceptible ABC isolates, based on investigator's clinical judgment.
- •Participant initiates treatment with SUL-DUR per routine clinical care. Participants who receive SUL-DUR within 24 hours prior to enrollment are also eligible to participate. The decision to treat the participant with SUL-DUR is made prior to and independently of study participation.
- •The participant has an expected survival of >48 hours at the time of written informed consent.
排除标准
- •A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics
研究组 & 干预措施
Acinetobacter baumannii-calcoaceticus complex (ABC)
Hospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care.
干预措施: Non-interventional (Other)
结局指标
主要结局
Incidence of maximum severity level of AESIs
时间窗: 28 days
Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs) defined as any event after exposure to sulbactam-durlobactam (SUL-DUR), or event already present that worsens in either intensity or frequency after exposure
时间窗: 28 days
Number of participants experiencing TEAEs
时间窗: 28 days
Incidence of maximum severity level of TEAEs
时间窗: 28 days
Incidence of serious TEAEs
时间窗: 28 days
Percentage of participants experiencing Adverse Events of Special Interest (AESIs) defined as an AE or SAE of concern specific to the sponsor, for which ongoing monitoring is needed. AESIs include: Hypersensitivity reactions, including anaphylaxis.
时间窗: 28 days
Incidence of related AESIs as assessed by the investigator
时间窗: 28 days
Incidence of related TEAEs as assessed by the investigator.
时间窗: 28 days
Number of participants experiencing AESIs
时间窗: 28 days
Incidence of serious AESIs
时间窗: 28 days
次要结局
- Actual observed values over time of liver function tests(Baseline and Day 28)
- Change from baseline values of liver function tests(Day 28)
- Actual observed values over time of systolic blood pressure(Baseline and Day 28)
- Change from baseline values over time of systolic blood pressure(Day 28)
- Actual observed values over time of diastolic blood pressure(Baseline and Day 28)
- Change from baseline values of diastolic blood pressure(Day 28)
- Actual observed values over time of temperature(Baseline and Day 28)
- Change from baseline values of temperature(Day 28)
- Actual observed values over time of pulse rate(Baseline and Day 28)
- Change from baseline values of pulse rate(Day 28)
- Actual observed values over time of respiration rate(Baseline and Day 28)
- Change from baseline values of respiration rate(Day 28)
- Summary of observed values over time of ECG QT measurements(Baseline and Day 28)
- Summary of observed values over time of platelets(Baseline and Day 28)
- Change from baseline values over time of ECG QT measurements(Day 28)
- Summary of observed values over time of hemoglobin(Baseline and Day 28)
- Change from baseline values over time of hemoglobin(Day 28)
- Summary of observed values over time of white blood count(Baseline and Day 28)
- Change from baseline values over time of white blood count(Day 28)
- Change from baseline values over time of platelets(Day 28)