ETUDE DE LA PHARMACOCINETIQUE DE L’ASSOCIATION PIPERACILLINE – TAZOBACTAM EN UTILISATION INTRA-VEINEUSE CONTINUE CHEZ L’ENFANT NEUTROPENIQUE FEBRILE .
Phase 1
- Conditions
- febrile episodes in neutropenic patientsMedDRA version: 9.1Level: LLTClassification code 10053223Term: Febrile aplasia
- Registration Number
- EUCTR2008-005131-15-FR
- Lead Sponsor
- CHRU de Lille
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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
Allergy to pipéracilline-tazobactam.
hospitalisation for hyperthermy without aplasia
Aplasia no febrile
Refusal of parents
Allergy to aminosids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method