Investigation on how children with cancer and fever metabolise the antibiotic, Piperacillin-tazobactam (PT) for the purpose of optimising the antibiotic treatment in this group of patients.

Phase 1

• Conditions: Pediatric oncology patients with fever; MedDRA version: 20.0Level: LLTClassification code 10051312Term: Neutropenic feverSystem Organ Class: 100000004851; MedDRA version: 20.0Level: LLTClassification code 10076734Term: Chemotherapy induced neutropeniaSystem Organ Class: 100000004851; MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004281-10-DK
• Lead Sponsor: Department of Pediatric oncology, Aarhus University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-06
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Children with cancer and fever who get admitted to the paediatric oncology department and start Tazocin treatment
- 6 months - 18 years
- All cancer types can be included
- A child can participate a maximum of 3 times in case of several fever episodes
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Babies that are only breast or bottle feed
- Not possible to take blood samples from the child's central venuous catheter
- Weight < 8 kg

Study & Design

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