NCT03560557

Brief Summary

WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine \& ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset

Trial Health

100
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

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

Study Start

First participant enrolled

August 1, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

5.2 years

First QC Date

June 6, 2018

Last Update Submit

January 21, 2021

Conditions

Critical IllnessPharmacokinetics

Keywords

PharmacokineticsMeropenemCritical illnessCapillary leakAugmented renal clearance

Outcome Measures

Primary Outcomes (1)

  • Risk factors for target non attainment

    risk factors will be assessed by comparing patients who attain target vs. those who don't

    on day of sampling

Eligibility Criteria

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

Critically ill patients with sepsis and receiving meropenem

You may qualify if:

  • Severe sepsis or septic shock
  • Admitted to an ICU ward
  • Treated with meropenem

You may not qualify if:

  • eGFR(CKD-EPI) \< 70ml/min/1.73m²
  • Renal replacement therapy
  • Pregnancy
  • DNR code 1-3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gijsen M, Elkayal O, Annaert P, Van Daele R, Meersseman P, Debaveye Y, Wauters J, Dreesen E, Spriet I. Meropenem Target Attainment and Population Pharmacokinetics in Critically Ill Septic Patients with Preserved or Increased Renal Function. Infect Drug Resist. 2022 Jan 8;15:53-62. doi: 10.2147/IDR.S343264. eCollection 2022.

    PMID: 35035223DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, urine, bronchoalveolar lavage fluid

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Isabel Spriet, PharmD PhD

    UZ Leuven

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 18, 2018

Study Start

August 1, 2012

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 22, 2021

Record last verified: 2021-01