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Candidiasis, Invasive clinical trials

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NCT ID: NCT01716988 Completed - Critical Illness Clinical Trials

Pharmacokinetics of Micafungin in Critically Ill Patients

Start date: October 2012
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01666769 Completed - Clinical trials for Invasive Candidiasis

Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation

Start date: January 2013
Phase: Phase 1
Study type: Interventional

Determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO).

NCT ID: NCT01490684 Completed - Clinical trials for Invasive Candidiasis

Invasive Candidiasis in Saudi ICUs

ICIP-SA
Start date: August 2012
Phase:
Study type: Observational

Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in Saudi Arabia is not well studied. This observational study objectives include to determine the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill patients in Saudi Arabia.

NCT ID: NCT01165320 Completed - Aspergillosis Clinical Trials

A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)

Start date: July 6, 2010
Phase: Phase 2
Study type: Interventional

The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.

NCT ID: NCT01122368 Completed - Mycoses Clinical Trials

A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects

INTENSE
Start date: July 13, 2010
Phase: Phase 2
Study type: Interventional

Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.

NCT ID: NCT01047267 Completed - Critically Ill Clinical Trials

Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

Start date: June 2010
Phase: N/A
Study type: Observational

The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.

NCT ID: NCT00786903 Completed - Clinical trials for Invasive Candidiasis

Candida Spp. in the Lower Respiratory Tract: Harmless Residents or Pathogen?

Start date: November 2008
Phase: N/A
Study type: Observational

In critically ill patients Candida spp. are frequently isolated from respiratory tract secretions such as endotracheal aspirates and bronchoalveolar lavages (BAL) and are most often considered as colonizers of the respiratory tract. In contrast, pneumonia due to infection with Candida spp. is rare and is diagnosed by histological demonstration of the yeast in lung tissue with associated inflammation. In spite of this, preemptive antifungal therapy based on isolation of Candida spp. from the respiratory tract is often initiated in critically ill patients. The disadvantages of this approach include increased selective pressure for the development of antimicrobial resistance, potential risks of adverse drug reactions and high treatment costs. On the other hand, immediate administration of appropriate antifungal therapy has been shown to be an important predictor of favorable outcome for patients with invasive fungal infections. Therefore, the development of reliable diagnostic measures for the detection of invasive pulmonary candidiasis is crucial. The overall objective of the proposed research project is to identify diagnostic strategies to differentiate between Candida colonization and Candida infection of the lower respiratory tract in critically ill patients. The proposed projects intends to test the hypothesis that 1.) invasive Candida strains from the lower respiratory tract differ from colonizing Candida strains with regard to production and expression of putative virulence factors and/or that 2.) patients suffering from pulmonary invasive candidiasis differ from patients colonized by Candida spp. with regard to inflammatory markers, other serum markers (fungal antigen) and composition of indigenous pulmonary bacterial flora.

NCT ID: NCT00761267 Completed - Candidemia Clinical Trials

Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

Start date: February 2009
Phase: Phase 3
Study type: Interventional

Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - <18 years) with invasive candidiasis, including candidemia (ICC).

NCT ID: NCT00689338 Completed - Clinical trials for Invasive Candidiasis

Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

ICE
Start date: July 2008
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

NCT ID: NCT00672841 Completed - Clinical trials for Invasive Candidiasis

β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients

Start date: June 2008
Phase: N/A
Study type: Interventional

This 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.