ClinicalTrials.Veeva

Menu

Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.

U

University Medical Center Groningen (UMCG)

Status and phase

Completed
Phase 4

Conditions

Critically Ill

Treatments

Drug: Cefotaxime

Study type

Interventional

Funder types

Other

Identifiers

NCT02560207
2014/468

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Intermittent cefotaxime
Active Comparator group
Description:
Cefotaxime 1 gram (1000 mg) is to be administered 4 times daily for 4 days
Treatment:
Drug: Cefotaxime
Continuous cefotaxime
Experimental group
Description:
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 .
Treatment:
Drug: Cefotaxime

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems