The effects of increased renal function on the blood concentration dynamics of antibiotic piperacillin/tazobactam

Phase 1

• Conditions: The state of renal hyperfiltration during infection in children and young adults with malignant or non-malignant haematological or oncological diagnosis; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2016-003374-40-EE
• Lead Sponsor: niversity of Tartu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-24
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Malignant or non-malignant haematological or oncological diagnosis
2. Chemotherapy or immunosuppressive therapy administered within last 12 months
3. Age from 6 months to 25 years
4. Clinically indicated and ordinated treatment with piperacillin/tazobactam based on the discretion of treating physician
5. Central venous, venous or arterial catheter inserted on clinical indications
6. eGFRcr > 80 ml/min/1.73 m2
7. Informed consent, if minor obtained from parents or legitimate representative of the child

Are the trial subjects under 18? yes
Number of subjects for this age range: 49
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of allergic reactions to piperacillin/tazobactam, penicillin’s, or other ß-lactam antibiotics or iohexol
2. Thyreotoxicosis
3. Presence of external drain
4. Ascites or generalised oedema
5. Received chemotherapy or immunosuppressive therapy during the last 24 hours
6. Received iohexol during last 24 hours
7. Participation in any other clinical study of investigational drugs within 4 weeks

Study & Design

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