Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033982
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-04-18
Brief Title:
Posaconazole to Treat Invasive Fungal Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Open Label Limited Access Protocol of Posaconazole in Invasive Fungal Infections
Status:
COMPLETED
Status Verified Date:
2007-02-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
We seek to use the experimental triazole antifungal Posaconazole in the treatment of patients with invasive fungal infections that are resistant or refractory to the best available treatment or who are unable to tolerate the best available treatment We have observed significant short and long term toxicities from amphotericin and its various preparations in our patients with chronic granulomatous disease CGD and Hyper IgE recurrent infection syndrome HIE or Jobs We now have now had 5 CGD patients on dialysis and several more have progressive renal failure all thought due to high dose prolonged amphotericin In addition many of our more severely affected CGD patients have had multiple thoracic surgeries leading to reduced lung capacity Several of our HIE patients have persistent fungal lung infections that have not cleared with extensive therapy with amphotericin andor other new triazole antifungals Therefore agents of high tolerability and high potency are still desperately needed Posaconazole has a broad spectrum of action against a large number of molds and fungi at easily achievable concentrations in plasma It has a favorable toxicity profile and has performed well in clinical trials to date This drug will be administered orally twice daily Close monitoring of tolerance toxicity and efficacy will be performed We anticipate enrollment of up to 50 patients over the next 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-I-0171 | None | None | None |