Measurement of the blood concentration of the antibiotic piperacillin and individual drug dosage in patients with febrile neutropenia after chemotherapy

Phase 1

• Conditions: Patients with febrile neutropenia after myelo-suppressive chemotherapy treated with piperacillin/tazobactam; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-002388-33-DE
• Lead Sponsor: Friedrich-Schiller-University Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-15
• Last Update Posted: 25 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 208

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 <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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified