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Temocillin Pharmacokinetic in Hemodialysis

NCT02285075 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-01-05

No results posted yet for this study

Summary

The current study aimed to explore the pharmacokinetics of temocillin in patients treated with haemodialysis and to demonstrated whether or not the pharmacodynamics target of a time above a MIC of 16 mg/L of more than 40 and 60 % of the dosing interval could be obtained with a dosing schedule of 1 gram/24 hours, 2 gram/48 hours and 3 gram/72 hours, all of these doses given after haemodialysis sessions only.

Conditions

  • Gram-Negative Bacterial Infections
  • Renal Failure Chronic Requiring Hemodialysis

Interventions

DRUG

temocillin PK/PD in haemodialysis

Pharmacokinetic study measuring total and free temocillin concentrations just before, and at 0.5, 3, 6, 12, 20 (before dialysis) and 24 (at the end of dialysis) hours after start of the infusion when patients were dialysed with a 1-day interval; just before and at 0.5, 3, 6, 12, 24, 36, 44 (before dialysis) and 48 (at the end of dialysis) hours after start of the infusion when patients were dialysed with a 2-day interval, and just before and at 0.5, 3, 6, 12, 24, 36, 48, 68 (before dialysis) and 72 (at the end of dialysis) hours after start of the infusion if patients were dialysed with a 3-day interval in order to determine basic PK and PD parameters in patients treated with intermittent haemodialysis and temocillin (Vd, T1/2, protein binding, clearance, reduction rate and T \> MIC of 8 and 16 mg/L).

Sponsors & Collaborators

  • Paul Tulkens, Louvain drug research institute, belgium

    collaborator UNKNOWN

  • Francoise Van Bambeke, Louvain drug research institute, belgium

    collaborator UNKNOWN

  • Ana Miranda Bastos, Louvain drug research institute, belgium

    collaborator UNKNOWN

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • Stefaan J Vandecasteele, MD, PhD · AZ Sint-Jan AV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02285075 on ClinicalTrials.gov