Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen in Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Compare treatment outcomes (clinical response) of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). composite endpoint
研究概览
简要总结
To compare the clinical response (efficacy) and the safety of the tigecycline once daily regimen versus the standard regimen (twice daily regimen). Clinical response was categorized as a cure, failure of treatment, or indeterminate outcome.24 Treatment success (Cure): defined as resolution of signs/symptoms of infection, microbiological cure (negative cultures after tigecycline use), improvement of infection markers (leukocytic count, C reactive protein, and procalcitonin).
Treatment failure: defined as persistence of signs/symptoms of infection despite antimicrobial therapy, deterioration of infection markers (leukocytic count, C reactive protein, and Procalcitonin).
Indeterminate response: subjects who do not have an outcome determination for reasons unrelated to the study drug or infection (e.g., loss to follow-up, withdrawal of consent, etc.) Safety will be assessed by the incidence of adverse events especially which leads to treatment discontinuation.36
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age 18 years or older.
- •Both males and females.
- •Diagnosis of infection has been established and tigecycline use is indicated (intra-abdominal, community-acquired pneumonia, skin Infections) or based on genetic testing and microbiological cultures (MDR Acinetobacter, MDR Stenotrophomonas, MDR Enterobacteriaceae, etc.)
排除标准
- •Pregnancy and lactation.
- •Bloodstream infections (BSI) and urinary tract infections (UTIs).
- •Refusal of attending staff or patient, or family.
- •Contraindications to tigecycline, such as hypersensitivity and allergy.
- •Patients receiving ≤ 1 day of tigecycline (insufficient length of therapy).
- •Patients who have acute physiology and chronic health evaluation (APACHE 2) score of more than 35 (high risk of mortality).
- •Do not resuscitate/do not intubate (DNR, DNI) patients.
研究组 & 干预措施
Control arm : Usual doses of tigecycline
Tigecycline standard dose (100 mg loading dose then 50 mg every 12 hours) or (200 mg loading dose then 100 mg every 12 hours). For hepatic patients with a Child-Pugh score (C), the loading dose is 100 mg, then 25 mg every 12 hours
干预措施: Usual doses of tigecycline (Drug)
Tigecycline once daily regimen
Tigecycline once-daily regimen (100 mg once daily) or (200 mg once daily). For hepatic patients with Child-Pugh score (C), the loading dose is 100 mg then 50 mg every 24 hours.
干预措施: Tigecycline once daily regimen (Drug)
结局指标
主要结局
Compare treatment outcomes (clinical response) of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). composite endpoint
时间窗: 28 days
Composite clinical response, defined as improvement of inflammatory markers (CRP, Procalcitonin), clinical improvement permitting ICU discharge, and absence of need to modify tigecycline therapy (no escalation or addition of other antibiotics), will be assessed at different time points during the study period. The response is classified as 1- Treatment success (Cure) by improvement of the SOFA score, improvement of infection markers ( CRP, Procalcitonin), and by the need for ICU stay ( ICU length of stay) 2- Treatment failure by an increase of SOFA score, an increase of infection markers ( CRP, Procalcitonin), need to change tigecycline to another antibiotic, or to add on another antibiotic, and death 3) Indeterminate response for drop-out patients and incomplete minimal duration of therapy
Compare the safety of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen).
时间窗: 28 days
1\. Tigecycline-induced hyperbilirubinemia will be assessed by comparing the baseline bilirubin level to the follow-up level at determined intervals (3 days, 5 days), allowing for comparison of the incidence of hyperbilirubinemia between the two study groups. .
次要结局
- Infection markers change between the two groups (C-reactive protein (CRP)(28 days)
- Vasopressor needs (only in septic shock patients).(28 days)
- - Intensive care unit (ICU) and in-hospital mortality between the two groups.(28 days)
- Compare the incidence of tigecycline-induced vomiting between the two groups(28 days)