NCT02560207

Brief Summary

This study evaluates target attainment after either intermittent intravenous bolus or intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_4

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 22, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

September 22, 2015

Last Update Submit

October 26, 2016

Conditions

Critically Ill

Outcome Measures

Primary Outcomes (1)

  • Cefotaxim serum concentrations

    Cefotaxime serum concentrations, total and unbound, will be determined. The Pharmacokinetic/Pharmacodynamic (PK/PD) target of total serum concentration of 4 times above minimal inhibitory concentration (MIC) ascertains that the unbound drug serum concentration will be above the MIC value of 1 mg/mL, which is determined to be the minimum target.

    40 min, 1 hour, 2, 4, 8, 12 and 24 hours; 36h; 48 h; 60h; 72h; 84h and 96h post administration

Secondary Outcomes (1)

  • Area under the curve of cefotaxim

    0-96h post administration

Study Arms (2)

Intermittent cefotaxime

ACTIVE COMPARATOR

Cefotaxime 1 gram (1000 mg) is to be administered 4 times daily for 4 days

Drug: Cefotaxime

Continuous cefotaxime

EXPERIMENTAL

After a 1 gram (1000 mg) Cefotaxime loading dose, Cefotaxime 4 gram (4000 mg) is to be administered as a continuous infusion in 24h for 4 days .

Drug: Cefotaxime

Interventions

CefotaximeDRUG

To assess the influence of administration route on target attainment cefotaxime is administered via two IV routes.

Also known as: Claforan
Continuous cefotaximeIntermittent cefotaxime

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to intensive care
  • Able to give informed consent by themselves or informed consent can be obtained via next of kin
  • Indication for treatment with cefotaxime (as judged by treating physician) in the context of our standard treatment protocol of Selective decontamination of the digestive tract (SDD).

You may not qualify if:

  • Renal replacement therapy
  • Contra-indication for cefotaxime, including known or suspected allergy to cefotaxime
  • No indication for an arterial line; an arterial line will not be placed solely for the purpose of this study; thus, only patients with an indication for an arterial line outside this protocol are eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

  • Aardema H, Bult W, van Hateren K, Dieperink W, Touw DJ, Alffenaar JC, Zijlstra JG. Continuous versus intermittent infusion of cefotaxime in critically ill patients: a randomized controlled trial comparing plasma concentrations. J Antimicrob Chemother. 2020 Feb 1;75(2):441-448. doi: 10.1093/jac/dkz463.

    PMID: 31697336DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Cefotaxime

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jan G Zijlstra, MD, PhD

    Department of Critical Care, UMCG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 25, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

NL(1)