Temocillin Pharmacokinetic in Hemodialysis

NCT02285075 | Completed Phase 4 DMC

• 1 other identifier: SVDC Temocillin 1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

temocillin; PD/PD; T>MIC

Outcome Measures

Primary Outcomes (1)

• % of the dosing interval time above an MIC of 8 and 16 mg/L (% T>MIC 8 or 16 mg/L)

  Is T \> MIC 8 and 16 mg/ML \> 40 or 60 %

  two to ten days

Secondary Outcomes (6)

• Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis

  two to ten days

• Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis

  two to ten days

• Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis

  two to ten days

• Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis

  two to ten days

• Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis

  two to ten days

Study Arms (1)

temocillin PK/PD in haemodialysis

OTHER

Pharmacokinetic study measuring total and free temocillin concentrations in patients treated with haemodialysis receiving 1 gram temocillin for a 1 day interval, 2 gram temocillin for a two day interval and 3 gram temocillin for a 3 day interval to the next dialysis session

Drug: temocillin PK/PD in haemodialysis

Interventions

temocillin PK/PD in haemodialysis DRUG

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).

temocillin PK/PD in haemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients under treatment with haemodialysis for ESRD for whom a treatment with temocillin was indicated according to the attending physician were eligible for the study.

You may not qualify if:

• an age of less than 18 years
• an estimated life-expectance of \< 24 hours due to major co-morbid conditions
• pregnancy
• an IgE-mediated allergy to penicillins
• patients not giving informed consent.

Sponsors & Collaborators

• AZ Sint-Jan AV: lead
• Paul Tulkens, Louvain drug research institute, belgium: collaborator
• Francoise Van Bambeke, Louvain drug research institute, belgium: collaborator
• Ana Miranda Bastos, Louvain drug research institute, belgium: collaborator

Study Sites (2)

AZ Sint-Jan Brugge Oostende AV

Bruges, 8000, Belgium

Location

Louvain Drug Research Institute (LDRI)

Brussels, 1020, Belgium

Location

Related Publications (2)

• Miranda Bastos AC, Vandecasteele SJ, Tulkens PM, Spinewine A, Van Bambeke F. Development and validation of a high performance liquid chromatography assay for the determination of temocillin in serum of haemodialysis patients. J Pharm Biomed Anal. 2014 Mar;90:192-7. doi: 10.1016/j.jpba.2013.12.002. Epub 2013 Dec 12.

  PMID: 24389461 RESULT

• Miranda Bastos AC, Vandecasteele SJ, Spinewine A, Tulkens PM, Van Bambeke F. Temocillin dosing in haemodialysis patients based on population pharmacokinetics of total and unbound concentrations and Monte Carlo simulations. J Antimicrob Chemother. 2018 Jun 1;73(6):1630-1638. doi: 10.1093/jac/dky078.

  PMID: 29579214 DERIVED

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Interventions

Dialysis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Stefaan J Vandecasteele, MD, PhD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stefaan Johan Vandecasteele, MD, PhD

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: November 6, 2014
• Study Start: June 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

BE (2)