Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micafungin |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity. | Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores. | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of micafungin in ICU patients. | Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin. | 4 days |
| Time (in days) to culture conversion. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with invasive candidiasis admitted to an intensive care unit.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28971861 | Derived | Boonstra JM, van der Elst KC, Veringa A, Jongedijk EM, Bruggemann RJ, Koster RA, Kampinga GA, Kosterink JG, van der Werf TS, Zijlstra JG, Touw DJ, Alffenaar JWC. Pharmacokinetic Properties of Micafungin in Critically Ill Patients Diagnosed with Invasive Candidiasis. Antimicrob Agents Chemother. 2017 Nov 22;61(12):e01398-17. doi: 10.1128/AAC.01398-17. Print 2017 Dec. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002177 | Candidiasis |
Not provided
Not provided
Not provided
Not provided
Not provided
Number of days untill cultures are negative.
| max 28 days |
| Correlation of the plasma concentration of micafungin with response to treatment. | Correlation of the level of micafungin concentration with outcome. | max 28 days |
| Correlation of the plasma concentration of micafungin with inflammation parameters. | Correlation of the level of micafungin concentration with interleukin-6, interleukin-8 and procalcitonin. | 4 days |
| Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio. | Area under the concentration-time curve of micafungin devided by the minimal inhibitory concentration of the candida species. | max 28 days |
| Composing a pharmacokinetic model of micafungin in critically ill patients. | Composing a pharmacokinetic model of micafungin to estimate the 24-hours AUC of micafungin based on limited samples. | max 28 days |
| Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio. | Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species. | 28 days |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |