Mycoses Clinical Trial
Official title:
An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
Invasive fungal infections are often life-threatening in persons with immunocompromise.
Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at high risk
for these infections. Patients undergoing bone marrow transplantation, receiving prolonged
corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS
are also at risk. With the use of currently approved antifungal therapy, many of these
infections may still be associated with a high mortality. Amphotericin B in its conventional
form, is the current standard treatment for most life-threatening fungal infections. Because
of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B
have been sought. Alternated agents include three lipid formulations of amphotericin B,
fluconazole, itraconazole. Although all of these agents are associated with a decrease in
adverse effects, their efficacy in most life-threatening fungal infections 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 many fungal pathogens in vitro.
In animal models and early human trials this new agent has been shown to be effective
against aspergillosis. It has been shown to be well-tolerated and is available in an
intravenous and oral formulation.
This is a non-comparative, open label study to evaluate the efficacy, safety and toleration
of voriconazole in the treatment of invasive fungal infections. This agent will be used as
primary therapy in those fungal infections in which no antifungal agent is currently
approved or in patients unable to tolerate the approved agent. Voriconazole will also be
used as a secondary treatment in those patients who have failed therapy with the primary
approved agent or are unable to tolerate that agent or have unacceptable toxicity.
Invasive fungal infections are often life-threatening in persons with immunocompromise.
Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at high risk
for these infections. Patients undergoing bone marrow transplantation, receiving prolonged
corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS
are also at risk. With the use of currently approved antifungal therapy, many of these
infections may still be associated with a high mortality. Amphotericin B in its conventional
form, is the current standard treatment for most life-threatening fungal infections. Because
of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B
have been sought. Alternate agents include three lipid formulations of amphotericin B,
fluconazole, and itraconazole. Although all of these agents are associated with a decrease
in adverse effects, their efficacy in most life-threatening fungal infections 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 many fungal pathogens in vitro.
In animal models and early human trials this new agent has been shown to be effective
against aspergillosis. It has been shown to be well-tolerated and is available in an
intravenous and oral formulation.
This is a non-comparative, open label study to evaluate the efficacy, safety, and toleration
of voriconazole in the treatment of invasive fungal infections. This agent will be used as
primary therapy in those fungal infections in which no antifungal agent is currently
approved or in patients unable to tolerate the approved agent. Voriconazole will also be
used as a secondary treatment in those patients who have failed therapy with the primary
approved agent or are unable to tolerate that agent or have unacceptable toxicity.
;
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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