Pharmacokinetics of Micafungin in Patients of Intensive Care Units

NCT02164890 | Completed Phase 4

• 1 other identifier: I13025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Invasive fungal infections (IFIs) are a frequent cause of morbidity and mortality in high-risk patients, such as immunocompromised patients. Candida is currently the predominant fungal pathogen in these patient populations and is associated with significant morbidity and a high mortality. Micafungin (MCF) is a semisynthetic compound belonging to the new class of antifungal agents, the echinocandin lipopeptides, that has potent in vitro and experimental in vivo activity against a variety of pathogenic Candida species and Aspergillus species. Its applied indications are so the treatment and/or the prophylaxis of Candida and Aspergillus infections. MCF is currently licensed for the treatment of candidiasis at doses of either 100 or 150 mg a day. The efficacy of MCF is linked to the area under the concentration-time curve over 24 h in the steady state divided by the MIC (AUC0-24/ MIC ratio). On one hand: \- It was demonstrated that 98% of invasive candidiasis patients with a MCF AUC/MIC ratio between 3 and 12 achieve microbiological clearance, as opposed to only 85% of those with an AUC/MIC ratio \< 3. In the case of infections by Candida parapsilosis, which exhibits drug MICs that are 50- to100-fold higher, 100% of patients with an AUC/MIC ratio \>285 achieve microbiological clearance, as opposed to 82% of those below that exposure level.(1) On the other hand:

• It is well known that patients of intensive care units (ICU) are characterized by particular pharmacokinetic parameters with higher apparent volume of distribution (VC/F) and/or higher apparent systemic clearance (CL/F). In a population of healthy volunteers, it was observed that CL/F of MCF presents a high interpatient variability.(2)
• Whether most ICUs patients achieve optimal AUC/MIC ratio thresholds at standard doses has not been investigated so far. In particular, lower AUCs might be reached in patients having the highest VC/F values. Such patients would then be at risk of therapy failure and would benefit from individualized-dosing strategies. In this context, the study of the pharmacokinetics of MCF in critically ill patients seems to be necessary.

Conditions

Invasive Candidiasis

Outcome Measures

Primary Outcomes (1)

• To describe micafungin concentrations over time,

  The evaluation of the PK model performance will be based on its ability: * To describe micafungin concentrations over time, * To explain the sources of inter-individual PK variability. It will be done by the calculation of the bias between concentrations predicted using the model and observed concentrations.

  3 weeks

Secondary Outcomes (1)

• To estimate the proportion of patients hospitalized in an ICU achieving the target AUC or AUC/MIC when receiving the recommended regimen

  3 weeks

Study Arms (1)

Pharmacokinetics of micafungin

OTHER

Other: micafungin

Interventions

micafungin OTHER

This is a pharmacokinetic study where a total number of 14 blood samples will be drawn per patient. Clinical and biological data will be concomitantly collected.

Pharmacokinetics of micafungin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill patients hospitalized in an ICU, with suspected or proven invasive fungal infections, for whom the decision has been made to start a treatment based on MCF.
• Age \> 18 years.
• Patients willing to give their written informed consent for their participation to the study.
• Patients affiliated to the French social security system or equivalent.

You may not qualify if:

• Patient for whom a treatment based on MCF has already been started
• Patient who have benefited from bone marrow transplantation
• Age \< 18 years
• Patient under legal protection
• Patient deprived of liberty
• Pregnant or breast-feeding woman or woman of childbearing potential without efficient contraception (based on declaration)
• Patient with any altered mental status or any psychiatric condition that would interfere with the understanding of the study

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

CHU de Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• Berrah R, Saint-Marcoux F, Monchaud C, Cointault O, Conseil M, Jaber S, Jung B, Woillard JB. From AUC/MIC to AUCss and Cmin: Optimizing Micafungin Therapy in the Critically Ill through Model-Informed Precision Dosing. AAPS J. 2025 Nov 11;28(1):18. doi: 10.1208/s12248-025-01173-z.

  PMID: 41219680 RESULT

MeSH Terms

Conditions

Candidiasis, Invasive

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 21, 2025

Record last verified: 2016-06

Locations

FR (1)