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Completed

NCT Number: NCT02560207

Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.

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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefotaxime

Drug

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

Other names: Claforan

Primary outcomes

  1. Cefotaxim serum concentrations

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

    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.

Secondary outcomes

  1. Area under the curve of cefotaxim

    Time frame: 0-96h post administration

    Based on the data from the primary outcome measure a pharmacokinetic model for ICU patients will be developed.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Does Continuous Cefotaxime Administration Improve Time to Attainment and Maintenance of Target Drug Levels in Critically Ill Patients?

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2015
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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