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Fungal Infection clinical trials

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NCT ID: NCT01303549 Completed - Liver Disease Clinical Trials

Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

AVALTRA
Start date: November 2011
Phase: Phase 4
Study type: Interventional

The study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B (3 mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.

NCT ID: NCT01288378 Completed - Leukemia Clinical Trials

Empirical Versus Preemptive Antifungal Therapy

Start date: March 2012
Phase: Phase 3
Study type: Interventional

RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan. PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.

NCT ID: NCT01169402 Completed - Fungal Infection Clinical Trials

Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)

Start date: July 2010
Phase: Phase 1
Study type: Interventional

Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper treatment of fungal infections would be difficult if not impossible. The investigators believe that giving prophylactic antifungal medication to all children on ECMO may prevent fungal infections from developing in the first place. Fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. The investigators have obtained FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the study. Blood samples will be collected at specific times around the first and second fluconazole doses to describe the PK and drug extraction by the ECMO circuit.

NCT ID: NCT01101386 Completed - Fungal Infection Clinical Trials

Study of Cyclodextrin (SBECD) and Voriconazole Blood Concentrations During Continuous Dialysis

Start date: May 2010
Phase: Phase 4
Study type: Observational

This study's primary objective is to determine if continuous renal replacement therapy (CRRT) can adequately remove the sulfobutylether-ß-cyclodextrin sodium (SBECD) vehicle from the blood so that intravenous voriconazole can be utilized in critically ill patients with renal dysfunction requiring dialysis. Secondarily, the pharmacokinetics of intravenous voriconazole and its metabolite (UK121-265) and adverse effects of SBECD accumulation will also be evaluated. The study hypothesis is that CRRT is effective at removing SBECD and allows patients to receive intravenous voriconazole without the concern of SBECD accumulation.

NCT ID: NCT01075984 Completed - Fungal Infection Clinical Trials

Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520)

Start date: February 23, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to collect pharmacokinetic (PK) information related to how well intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and tolerability of this new formulation. In addition, the PK, safety, and tolerability of switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be evaluated. The data collected in this study will be compared to data collected in previous studies. Individuals who have been diagnosed by their physicians with a blood disease or cancer that can affect their infection-fighting white blood cells will be asked to participate in the trial. Since these blood diseases and their treatments can weaken the immune system, they may put these individuals at a high risk for getting a serious fungal infection of their internal organs or blood (invasive fungal infection). As these fungal infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection. Enrollment into this study will take place in several stages (cohorts). The determination of which cohort an individual will be asked to participate in is based on which cohort is open at the site at the time the individual is approached to consider study participation.

NCT ID: NCT01062165 Completed - Obesity Clinical Trials

Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

Start date: February 2010
Phase: Phase 4
Study type: Interventional

This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.

NCT ID: NCT00936117 Completed - Leukemia Clinical Trials

Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn the amount of posaconazole that is in the body at different time points when given to patients with leukemia. The safety of this drug will also be studied. Objectives: Primary: To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing induction chemotherapy or relapsed or refractory patients who will receive salvage chemotherapy. Secondary: To evaluate the safety of posaconazole given as prophylaxis.

NCT ID: NCT00906633 Completed - Fungal Infection Clinical Trials

Seifem Surveillance of Antifungal Combination Therapy In Hematologic Italian Centers

SEIFEM COMBO
Start date: January 2009
Phase: N/A
Study type: Observational

This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).

NCT ID: NCT00904995 Completed - Leukemia Clinical Trials

Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis

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

Objectives: To investigate the relationship between the administration of intravenous (IV) and oral voriconazole (vori) and the occurrence of false positive (1,3) beta-d- glucan (BG) relative to the standard assessment criteria used to diagnose invasive fungal infection in patients with hematologic malignancies.

NCT ID: NCT00842504 Completed - Fungal Infection Clinical Trials

Alternate Day Micafungin: A PK Study in Pediatric Patients

Start date: July 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the pharmacokinetics of micafungin when it is given on an every other day schedule. The study will determine if every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience. Fifteen patients will be enrolled on this study. Blood samples for PK measurements will be obtained for 48 hours following a single dose of micafungin (3 mg/kg).