Pharmacokinetics of Micafungin in Critically Ill Patients
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2016 by University Medical Center Groningen
Sponsor:
University Medical Center Groningen
Information provided by (Responsible Party):
JWC Alffenaar, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT01716988
First received: October 8, 2012
Last updated: May 13, 2016
Last verified: February 2016
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Purpose
A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied.
The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.
| Condition |
|---|
|
Critical Illness Invasive Candidiasis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis |
Resource links provided by NLM:
Further study details as provided by University Medical Center Groningen:
Primary Outcome Measures:
- Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity. [ Time Frame: 4 days ] [ Designated as safety issue: No ]Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.
Secondary Outcome Measures:
- Pharmacokinetic parameters of micafungin in ICU patients. [ Time Frame: 4 days ] [ Designated as safety issue: No ]Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.
- Time (in days) to culture conversion. [ Time Frame: max 28 days ] [ Designated as safety issue: No ]Number of days untill cultures are negative.
- Correlation of the plasma concentration of micafungin with response to treatment. [ Time Frame: max 28 days ] [ Designated as safety issue: No ]Correlation of the level of micafungin concentration with outcome.
- Correlation of the plasma concentration of micafungin with inflammation parameters. [ Time Frame: 4 days ] [ Designated as safety issue: No ]Correlation of the level of micafungin concentration with interleukin-6, interleukin-8 and procalcitonin.
- Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio. [ Time Frame: max 28 days ] [ Designated as safety issue: No ]Area under the concentration-time curve of micafungin devided by the minimal inhibitory concentration of the candida species.
- Composing a pharmacokinetic model of micafungin in critically ill patients. [ Time Frame: max 28 days ] [ Designated as safety issue: No ]Composing a pharmacokinetic model of micafungin to estimate the 24-hours AUC of micafungin based on limited samples.
- Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio. [ Time Frame: 28 days ] [ Designated as safety issue: No ]Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species.
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Micafungin |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Adult patients with invasive candidiasis admitted to an intensive care unit.
Criteria
Inclusion Criteria:
- Treatment with micafungin.
- Admission to an ICU.
- Age ≥ 18 years.
- Invasive candidiasis.
Exclusion Criteria:
- Blood sampling not possible.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716988
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716988
Locations
| Netherlands | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, 9700 RB | |
| Contact: J WC Alffenaar, PharmD, PhD 0031503614070 j.w.c.alffenaar@umcg.nl | |
| Principal Investigator: J WC Alffenaar, PharmD, PhD | |
Sponsors and Collaborators
University Medical Center Groningen
More Information
| Responsible Party: | JWC Alffenaar, PharmD, PhD, University Medical Center Groningen |
| ClinicalTrials.gov Identifier: | NCT01716988 History of Changes |
| Other Study ID Numbers: | NL39246.042.12 |
| Study First Received: | October 8, 2012 |
| Last Updated: | May 13, 2016 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by University Medical Center Groningen:
|
Micafungin pharmacokinetics invasive candidiasis intensive care |
Additional relevant MeSH terms:
|
Critical Illness Candidiasis Candidiasis, Invasive Disease Attributes Pathologic Processes |
Mycoses Micafungin Echinocandins Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 23, 2016