NCT04096092

Brief Summary

Characterize teicoplanin PK in critically ill patients with a specific focus on alterations of exposure due to variability in renal function. In a prospective, observational, open-label study the investigators aim to define PK of free drug concentrations of teicoplanine in ICU and heamatology patients and define a PK model for Bayesian dose individualization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

September 18, 2019

Last Update Submit

January 30, 2023

Conditions

Bacterial Infections

Keywords

TeicoplaninPharmacokineticsCritically ill

Outcome Measures

Primary Outcomes (1)

  • Total drug clearance

    Pharmacokinetic curves will be taken

    4 days

Secondary Outcomes (2)

  • Volume of distribution

    4 days

  • Area under the curve

    4 days

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All critically ill patients (defined as ICU and hematology patients) with a suspected or proven bacterial infection who are already treated with teicoplanin as a part of routine clinical care are eligible for inclusion. A total of 30 patients will be included.

You may qualify if:

  • The patient is admitted to the ICU of the haematology department
  • Is managed with a central venous catheter or arterial line
  • Is treated with teicoplanin as a part of standard care

You may not qualify if:

  • Has previously participated in this study
  • Patient is admitted to the haematology department and receives any form of RRT other than continuous venovenous hemofiltration (CVVH).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Bacterial InfectionsCritical Illness

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 19, 2019

Study Start

January 15, 2020

Primary Completion

October 19, 2021

Study Completion

December 1, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

NL(1)