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Clinical Trials/EUCTR2016-004800-71-IT
EUCTR2016-004800-71-ITActive, not recruitingPhase 1

Determination of intraoperative levels of Cefoxitin during cardiac surgery requiring cardiopulmonary bypass in neonates, infants, children below, and above 40 kg.

Bambino Gesù Children's Hospital0 sites40 target enrollmentStarted: December 19, 2016Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •-Elective cardiac surgery schedule with the planned application of CPB.
  • •-Parents of elegible children, or their legal representative, able to consent and comply with protocol requirements.
  • •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

  • •-Urgent or emergent surgery
  • •-Antibiotic therapy (any) administered before surgery
  • •-Patients receiving, before surgery, any other form of extracorporeal treatment (i.e ECMO, CRRT)
  • •-Previous renal or hepatic dysfunction requiring need for antibiotic posology modification.
  • •-Surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin)
  • •-ELBW neonates.

Investigators

Sponsor
Bambino Gesù Children's Hospital

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