Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095
Status:
Terminated
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
Therapeutic options for serious fungal infections are limited by intrinsic and acquired
resistance to existing antifungal agents. For example, zygomycetes (such as Mucor spp.) are
intrinsically resistant to voriconazole and caspofungin. Yet, the only available therapeutic
option, amphotericin, is associated with significant renal toxicity, even in lipid
formulations. Posaconazole is a new antifungal drug, not yet Food and Drug Administration
(FDA) approved, but which has excellent in vitro activity against some intrinsically
resistant fungi such as the zygomycetes.
The intent of this trial is to provide access to posaconazole to patients with serious fungal
infections which are refractory to standard antifungal therapies or invasive fungal
infections for which there are currently no effective therapies. Secondly, the drug will also
be made available to patients with invasive fungal infections who:
- have experienced serious or severe toxicities while receiving standard antifungal
therapies;
- have pre-existing renal dysfunction which precludes use of standard antifungal
therapies; or
- are chronically immunosuppressed with a history of invasive fungal infections previously
treated with posaconazole in other clinical trials, and who require oral antifungal
suppressive therapy as maintenance treatment to prevent recurrence.
This is a multicenter, open-label, non-comparative experimental treatment use protocol. The
experimental treatment use protocol will provide the investigational medication posaconazole
where no other drug is commercially available. Posaconazole is given as an orally or
enterally administered suspension. The duration of therapy is at the discretion of the
investigator. Safety assessments will include an electrocardiogram [ECG] (to ensure no QTc
interval prolongation) performed at baseline and serum/urine pregnancy testing performed at
baseline and every three months after initiation of therapy. Plasma concentrations will be
obtained if there is evidence of clinical failure. No other tests will be performed
specifically for the experimental treatment use protocol.