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ETUDE DE LA PHARMACOCINETIQUE DE L’ASSOCIATION PIPERACILLINE – TAZOBACTAM EN UTILISATION INTRA-VEINEUSE CONTINUE CHEZ L’ENFANT NEUTROPENIQUE FEBRILE .

ETUDE DE LA PHARMACOCINETIQUE DE L’ASSOCIATION PIPERACILLINE – TAZOBACTAM EN UTILISATION INTRA-VEINEUSE CONTINUE CHEZ L’ENFANT NEUTROPENIQUE FEBRILE .

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-005131-15-FR
Enrollment
50
Registered
2008-10-21
Start date
2008-12-19
Completion date
Unknown
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

febrile episodes in neutropenic patients MedDRA version: 9.1 Level: LLT Classification code 10053223 Term: Febrile aplasia

Interventions

Trade Name: Tacocilline Pharmaceutical Form: Intravenous infusion

Sponsors

CHRU de Lille
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026