febrile episodes in neutropenic patients MedDRA version: 9.1 Level: LLT Classification code 10053223 Term: Febrile aplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age between 3 and 18 years old febrile aplasia during more 7 days Normal Renal functions No infection of nervous system central No septic shock No Knews resistance to pipéracilline-tazobactam. Informed consent of two parents Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria: Allergy to pipéracilline-tazobactam. hospitalisation for hyperthermy without aplasia Aplasia no febrile Refusal of parents Allergy to aminosids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pharmacokinetic of association pipéracilline-tazobactam in continuous infusion ;Secondary Objective: Efficacity and tolerance of association pipéracilline-tazobactam in continuous infusion ;Primary end point(s): serum level of association pipéracilline-tazobactam | — |
Countries
France