DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Pharmacokinetics of Micafungin in Patients of Intensive Care Units

Information source: University Hospital, Limoges
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invasive Candidiasis

Intervention: micafungin (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Limoges

Overall contact:
Pierre MARQUET, MD, Phone: (+33) 5 55 05 61 40, Email: pierre.marquet@unilim.fr

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.

Clinical Details

Official title: Pharmacokinetics of Micafungin in Patients of Intensive Care Units

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: To describe micafungin concentrations over time,

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- Patient enrolled in another clinical trial testing drugs or therapeutic strategies

(including the so-called "exclusion period")

Locations and Contacts

Pierre MARQUET, MD, Phone: (+33) 5 55 05 61 40, Email: pierre.marquet@unilim.fr

CHU de Montpellier, Montpellier 34295, France; Recruiting
Boris Jung
Additional Information

Starting date: June 2014
Last updated: June 17, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017