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 sites208 target enrollmentAugust 15, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with febrile neutropenia after myelo-suppressive chemotherapy treated with piperacillin/tazobactam
Sponsor: Friedrich-Schiller-University Jena
Enrollment: 208
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

August 15, 2016

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Friedrich-Schiller-University Jena

•\- 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