The purpose of this study is to provide posaconazole compassionate treatment to patients with
invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for
which there are no effective therapies; 3) with a prior history of serious, severe, or
life-threatening toxicities while receiving standard antifungal therapies, or 4) with
pre-existing organ dysfunction which precludes the use of standard antifungal therapies.
Inclusion Criteria:
General Inclusion Criteria:
- Adults (age >=18 years) of either gender and of any race.
- Children (age >= 2 to 17 years) of either gender and of any race, who are not eligible
for enrollment under any current clinical trial. Compassionate use will be permitted
only under the direct supervision of qualified experts in pediatric infectious
diseases with the written approval of the Schering Plough medical director (local
country operations or headquarters project director).
- Subject or his/her legally authorized representative has given signed, written
informed consent,
- Ability to take study medication orally by swallowing or via an enteral feeding tube.
- Subject is not considered eligible for any other clinical research program with
posaconazole.
Safety Related Inclusion Criteria
- Male or a female patient who meets any one of the following criteria:
- postmenopausal, surgically sterilized, or documented to have primary ovarian
failure due to prior cytotoxic chemotherapy or radiation therapy; abstinent from
sexual intercourse or practicing effective birth control. Effective birth control
methods must continue for at least 30 days after discontinuation of treatment
with posaconazole.
- Known to be non pregnant by history or (preferably) by negative serum or urine
pregnancy test prior to the first dose of posaconazole for all females of childbearing
potential.
- Not breast feeding or if lactating, willing to discontinue breast feeding during
treatment.
Invasive Fungal Infection Inclusion Criteria
- Each patient must have:
- A documented invasive fungal infection who have failed a reasonable trial of
other licensed antifungal agents, either due to progression or lack of
improvement of the infection, or
- Serious, severe or life-threatening toxicities related to current or prior
antifungal therapy, or
- An invasive fungal infection for which there are currently no effective
therapies.
- Patients with debilitating but not immediately life threatening fungal diseases, where
significant morbidity may result in disability and where prior antifungal therapy has
been unsuccessful (eg, chronic mucocutaneous candidiasis, recurrent oropharyngeal or
esophageal candidiasis with dehydration and malnutrition, or cutaneous
phaeohyphomycosis and mycetoma).
Exclusion Criteria:
- Women who are pregnant or who will continue to breast-feed infants.
- History of serious or severe hypersensitivity or idiosyncratic reactions to azole
antifungals.
- Patients who require ongoing treatment with any prohibited medication (see Core
Clinical Data Sheet and list of Prohibited Medications) and for whom an appropriate
washout period has not elapsed.
- Patients who are in a situation or have any condition requiring the use of prohibited
drugs or unstable medical conditions where the risk of therapy would exceed any
potential benefit i. e., hematological disorder such as unstable cardiac disorder
(including acute myocardial infarction or unstable myocardial ischemia/angina within
30 days, ventricular arrhythmia within 30 days, uncontrolled atrial fibrillation, or
atrial fibrillation/flutter with symptomatic bradycardia [sick sinus syndrome], or
unstable congestive heart failure) or impairment expected to be unstable or
progressive during the course of this study (e. g., recurrent or uncontrolled seizure
disorders, demyelinating syndromes, or progressive peripheral neuropathy).
- Patients receiving vinca alkaloids or anthracyclines within 24 hours of study
enrollment or requiring therapy with vinca alkaloids or anthracyclines within the
next 30 days for treatment of uncontrolled (pre-existing) malignancy or requiring
ongoing therapy with vinca alkaloids or anthracyclines, where the risk of toxicity
from these medicinal products is considered to be significant.
- Any condition requiring the use of prohibited drugs (please consult current product
labeling).
- Hepatic function tests: alanine amino transferase (ALT) or aspartate aminotransferase
(AST) >10 times upper limit of normal, or evidence of severe hepatic dysfunction based
on other clinical assessment.
