Infection Clinical Trial
Official title:
Open Label, Limited Access Protocol of Posaconazole in Invasive Fungal Infections
Verified date | February 20, 2007 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 20, 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
- 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 age 2 years and older will be eligible at this time. Pediatric Inclusion: Children age 2 and over are eligible. Children under 2 years are not currently eligible because of lack of any data on dose and tolerance. EXCLUSION CRITERIA: As set out in the company protocol. |
Country | Name | City | State |
---|---|---|---|
United States | Schering-Plough Research Institute | Kenilworth | New Jersey |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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 and antifungal resistance. Am J Med. 1996 Jun;100(6):617-23. — View Citation
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