Patients with febrile neutropenia after myelo-suppressive chemotherapy treated with piperacillin/tazobactam
Conditions
Sponsors
Friedrich-Schiller-University Jena
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 104
Exclusion criteria
Exclusion criteria: - Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal of the study is to examine if and in which extent the effect of a dose adjusted administration of piperacillin/tazobactam after therapeutic drug monitoring has a benefit on a stable fever recovery without changing the anti infective therapy in patients with neutropenia after myelo-suppressive cytostatic chemotherapy;Secondary Objective: - 30 day mortality - Infect associated 30 days mortality - Duration and cumulative doses of antibiotic therapy of the current fever episode - Number of dose adjustments/therapy cycle - Duration of combination therapy with anti-infective in the current fever episode - Days without antibiotics at hospital stay - Need of intensive care unit - Time spent in hospital - Antibiotic therapy costs - Occurrence of antibiotic resistant bacteria - Pharmacokinetic / pharmacodynamic indices - Days without antibiotics at stage of neutropenia - Recovery of the infection - Progression to SIRS/Sepsis - Rate of superinfection with another pathogen - Security (Side effects) ;Primary end point(s): stable fever recovery (yes/no) defined as 5 consecutive days without fever without any changes in the antibacterial therapy. This proportion of patients without fever under TDM will be compared according to the proportion of the control group.;Timepoint(s) of evaluation of this end point: Until the end of the therapy in accordance with the instructions of the treating physician or until 5 consecutive days without fever. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 30 day mortality - Infect associated 30 days mortality - Duration and cumulative doses of antibiotic therapy of the current fever episode - Number of dose adjustments/therapy cycle - Duration of combination therapy with anti-infective in the current fever episode - Days without antibiotics at hospital stay - Need of intensive care unit - Time spent in hospital - Antibiotic therapy costs - Occurrence of antibiotic resistant bacteria - Pharmacokinetic / pharmacodynamic indices - Days without antibiotics at stage of neutropenia - Recovery of the infection - Progression to SIRS/Sepsis - Rate of superinfection with another pathogen - Security (Side effects) ;Timepoint(s) of evaluation of this end point: During course of treatment with Pip / Taz and until day 30 or until discharge with a follow-up on day 30 | — |
Countries
Germany
Contacts
Public ContactProject Manager
Jena University Hospital - Centre for Clinical Studies
Outcome results
None listed