NCT02596984

Brief Summary

Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. Thus, studies performed so far show Caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. One of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. These results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed. The primary objective of this study is to assess Caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

March 16, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

3.1 years

First QC Date

November 3, 2015

Last Update Submit

June 12, 2019

Conditions

Shock

Keywords

Intensive Care UnitShockAntifungal agentPharmacokineticsSepsis

Outcome Measures

Primary Outcomes (2)

  • Caspofungin pharmacokinetic : clearance (ml.min-1)

    day 2 - day 3 - day 4

  • Caspofungin pharmacokinetic : volume of distribution (mL)

    day 2 - day 3 - day 4

Secondary Outcomes (2)

  • Caspofungin trough concentration

    day 2 - day 3 - day 4

  • proportion of patients for whom the trough concentrations are lower than the MIC (Minimum Inhibitory Concentration) 90 of Candida ( 1mg / L)

    day 2 - day 3 - day 4

Study Arms (1)

caspofungin

EXPERIMENTAL

Caspofungin will be administered according to the international recommendation.

Drug: Caspofungin

Interventions

CaspofunginDRUG

Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician. Caspofungin will be administered according to the international recommendation

caspofungin

Eligibility Criteria

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

You may qualify if:

  • Adult patients (age \> 18 y.o)
  • Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician
  • Requiring vasopressors
  • Admission in one of the participating ICUs.

You may not qualify if:

  • Pregnancy
  • Lack of affiliation to the National Medical Insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de CLERMONT-FERRAND

Clermont-Ferrand, 63000, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

ShockSepsis

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammation

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Michael DARMON, MD PhD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 4, 2015

Study Start

March 16, 2015

Primary Completion

May 1, 2018

Study Completion

May 31, 2018

Last Updated

June 14, 2019

Record last verified: 2019-06

Locations

FR(3)