Optimal Dosage of Caspofungin in Critically Ill Patients
Critically IllSuspected Invasive CandidiasisIntensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the presence of risk factors. 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. A study of caspofungin in ICU patients has found a high inter- and intra-individual variability in caspofungin concentration. Factors that caused subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin among patients with a higher disease severity score. As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur in critically ill patients and an adjusted dosage might be necessary in these patients.
Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation
Invasive CandidiasisDetermine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO).
A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive...
Fungal InfectionTo evaluate the safety, tolerability, and efficacy of caspofungin for the treatment of esophageal candidiasis and invasive candidiasis to support the registration of caspofungin for these indications in China.
Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive...
CandidiasisThe purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.
Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
CandidiasisThe purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive...
MycosesCandidiasis2 moreThe purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.
Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine...
Invasive CandidiasisEPICA-1 is a multicenter, open label, interventional study which will involve about 30 Internal Medicine Units throughout Italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. These patients will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test: this will allow collection of information on patients outcome. At the same time, patients will be also evaluated by means of blood culture, so that comparison will be possible between the two diagnostic tests (primary end-point of the study).
β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis...
Invasive CandidiasisThis is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.
CRITIC - Treatment of Candidemia and Invasive Candidiasis
CandidemiaInvasive CandidiasisPatients will receive 2mg/kg/day IV daily administration of AmBisome® over 30-60 minutes as a reaction to signs/symptoms and positive Candida culture
Empirical Antifungal Treatment in ICUS
Invasive CandidiasisInvasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.