Protocol Number: 02-I-0171

Title:

Open Label Limited Access Protocol of Posaconazole in Invasive Fungal Infections

Number:

02-I-0171

Summary:

This study will evaluate the safety and effectiveness of posaconazole for treating invasive fungal infections. New therapies for these infections are needed for patients who do not respond, to or cannot tolerate, standard treatment. These patients include those with immune defects who have significant side effects from treatment with amphotericin or other antifungals.

Patients 13 years of age or older who are on other primary NIH protocols with an invasive fungal infection 1) that does not respond to standard antifungal therapies; 2) for which there is no effective therapy; 3) who develop serious side effects from their current treatment; or 4) who have organ dysfunction that does not permit use of standard antifungal treatments may be eligible for this study. Candidates will be screened with a medical history, including a review of current and previous antifungal treatments, pregnancy test for women of childbearing potential, electrocardiogram (EKG), and detailed neurologic examination.

Participants will take either 200 mg (1 teaspoonful) of liquid posaconazole by mouth four times a day or 400 mg (two teaspoonfuls) twice a day for a period of 28 days to 24 months. (The physician will determine the duration of treatment.) Patients will have monthly follow-up visits during the treatment period and 1 month after treatment is completed for the following procedures:

- Detailed neurologic exam every 3 months

- Blood tests every month

- EKG every month

- Imaging studies, including chest x-ray, computed tomography (CT), magnetic resonance imaging (MRI) radionuclide scanning or ultrasound, every month until the infection has been stable for three determinations. Thereafter, imaging studies will be done every 3 months as long as the infection remains stable or improves.

On the last day of the study treatment period, participants will have a detailed neurologic exam and review of medications and medical complaints since their last visit.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

As set out in the company protocol.

All subjects must have a proven or probable fungal infection that is resistant to standard therapy, or to which therapy the patient is significantly intolerant. (Intolerance must include signs of intolerance such as fever, rigors, laboratory, abnormalities, as well as subjective symptoms).

Only subjects over age 13 will be eligible at this time.

Pediatric Inclusion:

Children age 13 and over are eligible.

EXCLUSION CRITERIA:

As set out in the company protocol.

Special Instructions: Currently Not Provided

Keywords:

Triazole

Refractory

Antifungal

Recruitment Keywords:

Fungal Infection

Conditions:

Granulomatous Disease, Chronic

Job's Syndrome

Infection

Investigational Drug(s):

Posaconazole

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Vanden Bossche H, Warnock DW, Dupont B, Kerridge D, Sen Gupta S, ImprovisiL, Marichal P, Odds FC, Provost F Mechanisms and clinical impact of antifungal drug resistanceJ Med Vet Mycol 1994;32 Suppl 1:189-202 Review No abstract availablePMID: 7722785

Martins MD, Rex JH Resistance to antifungal agents in the critical care setting: problems andperspectivesNew Horiz 1996 Aug;4(3):338-44 ReviewPMID: 8856751

Nguyen MH, Peacock JE Jr, Morris AJ, Tanner DC, Nguyen ML, Snydman DR,Wagener MM, Rinaldi MG, Yu VL The changing face of candidemia: emergence of non-Candida albicans species andantifungal resistanceAm J Med 1996 Jun;100(6):617-23PMID: 8678081

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