Active clinical trials for "Aspergillosis"

This will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8, after dosing with fluconazole 800 mg daily for 1 day (Day 4) and 400 mg daily orally for 4 days (Days 5 to 8). Up to twenty subjects will be included in two cohorts which will undergo the same dosing schedules of fluconazole and F901318 and undergo the same procedures. The first cohort will consist of 12 subjects studied in two groups of six subjects each. If there is clearly a difference in F901318 kinetics detectable before and after dosing with fluconazole in this first cohort, the second cohort will not be studied. If there is no clear difference, the second cohort will also be studied to give a final result. In this cohort, based on the pharmacokinetic findings in cohort 1, the dose of F901318 may be increased to up to 4 mg/kg to establish a dose suitable for phase 2 evaluation. PK sampling for plasma F901318 will continue from before the first dose up to and including 72 hours after dosing. PK sampling for fluconazole will continue from before the first dose and up to 72 hours after the fifth dose. A follow up visit will be conducted 7 +/- 2 days after discharge from the clinical unit following completion of blood sampling following the second dose of F901318 and the fifth dose of fluconazole. The second part of the study will take place if no appreciable change in the pharmacokinetics of either F901318 or fluconazole has been observed in either the first or the second cohorts in the first part of the study. This second part will enrol 12 subjects. These subjects will receive fluconazole 800 mg daily for one day (Day 1) and 400 mg daily orally for 4 days (Days 2 to 5) in combination with F901318 which will be given in a dose of up to 4 mg/kg IV bid for one day (Day 1) followed by 7 doses of intravenous F901318 up to 2.5 mg/kg bid (Days 2 to 5). Pharmacokinetic profiles of F901318 and fluconazole will be obtained during dosing and over a 72-hour period following the final dose of both compounds.

Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers

Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA stems from the fact that the disease is glucocorticoid-sensitive and early treatment can prevent progression to end-stage lung disease. Recently anti-Th2 therapies have been suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 responses and decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role of vitamin D in treating ABPA.

This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.

Aspergillus infection is an infectious complication which frequently occurs in cystic fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole and voriconazole in this indication has never been evaluated in a large prospective controlled clinical trial, even though many teams already use it. The ATCF study aims to assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for Aspergillus.

The purpose of this study is to see if giving people with CF and ABPA enough vitamin D to make their blood levels of the vitamin higher, will reduce the allergic response in their body and make the symptoms caused by ABPA better.

F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile.

Fever and infection are serious complications of cancer treatment such as bone marrow transplant, especially when white blood cell counts are low. When the number of white blood cells is below 500, the person has a condition called neutropenia and has a high risk of developing an infection. At the first sign of fever, antibiotics are started. However, antibiotics do not kill fungus germs, and fungal infections may be difficult to treat. Thus, the prevention of fungal infections in this population is important. The only medicine approved for prevention of fungal infections is fluconazole, which prevents some but not all types of such infections. A new antifungal medication called FK463 works against more types of fungal infections than fluconazole does. This study will compare the effectiveness, safety, and tolerance of FK463 as compared with fluconazole. Eight hundred patients will be enrolled in this study. They will be randomly assigned to receive either fluconazole or FK463. Before the medicine is begun, a physical exam as well as a blood sample, mouth swab, urine sample, and chest x-ray will be done. The fluconazole or FK463 will be administered once a day for one hour into the bloodstream through a catheter in the vein. Blood tests will be taken twice a week. Cultures from the blood, mouth, and urine will be taken throughout the study. X-rays and CT scans will only be taken if a fungal infection is suspected. If fever develops, blood will be drawn to check for fungi. If fever and neutropenia continue for more than 4 days, FK463 or fluconazole will be stopped and a standard medication called amphotericin B will be started. Both FK463 and fluconazole will be administered until white blood cell count returns to greater than 500 (signifying recovery from neutropenia), or up to 42 days after transplantation. Patients will be evaluated 4 weeks after the medicine is stopped.

The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents. This trial is a Phase II multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple centers. The patient population will consist of patients with proven, deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents. Voriconazole will be administered initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response.

Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase in immunocompromised persons in our population. Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at the highest risk for acute aspergillosis. Patients undergoing bone marrow transplantation, receiving prolonged corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. Even with antifungal therapy, aspergillosis in its acute invasive forms has a high mortality. In bone marrow transplantation patients and in those whose infection involves the brain, this mortality is greater than 90%. Amphotericin B in its conventional form, is the current standard treatment for this disease. Response to therapy with amphotericin B usually ranges between 20-60% in most studies. The higher response rates are usually seen in those patients who can tolerate this agent for at least 14 days. Because of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B have been sought. These currently include liposomal forms of amphotericin B and itraconazole. Although these forms show a decrease in adverse effects, the efficacy of these drugs has not been shown to be equivalent to conventional amphotericin B. Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US. This azole has been shown active against Aspergillus spp. in vitro, and in animal models and early human trials to be effective against aspergillosis. It has been shown to be well-tolerated and is available in an intravenous and oral formulation. This study will evaluate the efficacy, safety, and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients. Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio.