Therapeutic drug monitoring (TDM) for personalized antibiotic treatment with piperacillin-tazobactam (PipTaz) in patients with febrile neutropenia after myelo-suppressive cytostatic chemotherapy - Target-F

Friedrich-Schiller-University Jena0 个研究点目标入组 208 人开始时间: 2016年8月15日最近更新: 2018年6月25日

适应症

试验速览

暂无简介。

•- Fever (temperature >38.3°C at one time or temperature >38.0°C twice in 2 hours) and existing neutropenia after myelo-suppressive cytostatic chemotherapy (leucocytes <1,0Gpt/l or netrophile granulocytes <0,5Gpt/l)
•- Planned or started therapy with the antibiotic Piperacillin-Tazobactam
•- Written consent of the Patient
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 104
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 104

•- Age <18 years
•- Pregnancy/breast feeding women
•- Women in childbearing age, whithout women with following criteria:
•o Post-menopausal (12 month normal amenorhoea or 6 month amenorhoea with FSH at serum >40mlU/ml)
•o Postoperative (ovarectomy at both sides with or without hysterectomy)
•o Regular use of a preventive measure
•o Sexual abstinence
•o Vasectomia of the partner
•- Not able to give consent
•- Known hypersensitivity against
•o ß-Laktam antibiotica or other
•o components oft he investigated substance (Pip/Taz)
•- pretreatment with Pip/Taz >18g in the last 24h before randomisation
•- if the patient is participating at other interventional clinical trials
•- previous inclusion inTARGET-FN
•- hepatic impairment (Child-Pugh C)
•- Renal insufficiency (eGFR<40ml/min)
•- Infection which needs specific anti-infective treatment (e.g. endocarditis or invasive fungal infection)
•- Life expectancy <90 days due to other co-morbidities

发起方

Friedrich-Schiller-University Jena