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Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.

NCT ID: NCT02560207

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Critically ill patients have other pharmacokinetic/pharmacodynamic profiles than healthy volunteers. Suboptimal, both under- and overdosing of antibiotics is an important threat in this patient category. Given the time-dependent character of beta-lactam antibiotics continuous dosing as opposed to traditional intermittent dosing is likely to render better target attainment and maintenance and might improve clinical outcome.

Conditions

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intermittent cefotaxime

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

Group Type ACTIVE_COMPARATOR

Cefotaxime

Intervention Type DRUG

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

Continuous cefotaxime

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 .

Group Type EXPERIMENTAL

Cefotaxime

Intervention Type DRUG

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

Interventions

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Cefotaxime

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

Intervention Type DRUG

Other Intervention Names

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Claforan

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. J.G. Zijlstra

prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan G Zijlstra, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care, UMCG

Locations

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University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 31697336 (View on PubMed)

Other Identifiers

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2014/468

Identifier Type: -

Identifier Source: org_study_id