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Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections Clinical research trials and Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections. Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections clinical trial. Subjects frequently obtain the most expert healthcare possible for their Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections  Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections
Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections
For Condition: Mycoses
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This protocol provides for emergency treatment with the experimental anti-fungal drug voriconazole for patients with life-threatening invasive fungal infections. The increase in the number of patients whose immune function is suppressed because of chemotherapy, tissue or organ transplantation, or HIV infection has led to an increase in fungal infections. New drugs are needed to combat these infections in patients who do not respond to or cannot tolerate standard treatments. Patients on other primary NIH protocols who have an invasive life-threatening fungal infection that does not respond to currently available treatments or who cannot tolerate these treatments may be eligible for this study. Participants will have a blood test and a physical examination before receiving voriconazole. They will receive voriconazole twice a day either as an infusion into a vein or as tablets taken by mouth. Adult patients will be asked to provide a blood sample any time after the first dose of voriconazole to be used for developing a test to measure voriconazole concentration in the blood. Patients will be evaluated about 10 days after starting treatment and then at least once every 4 weeks with a symptom check and blood test.
Details: The increase in the number of immunosuppressed patients as a result of more aggressive chemotherapy, transplantation, HIV infection has lead to an increase in the incidence of invasive fungal infections. Moreover, despite the availability of newer, less toxic preparations of Amphotericin B and azole antifungals such as fluconazole and itraconazole, invasive mycoses remain a therapeutic challenge. Voriconazole is a new triazole that has shown in phase II studies to be very active against Aspergillus sp. Its side effect profile has been very benign, comparable with those of other FDA approved triazoles. In vitro studies also show that voriconazole has a very broad spectrum ranging from opportunistic to endemic fungi. In addition, the availability of intravenous and oral formulations add to its potential advantages because the therapy of these infections usually require long courses on antifungals. In this study, voriconazole is used as a salvage therapy for those patients who are unable to tolerate or who have failed other antifungal therapies. Because of the abundance of immunocompromised patients at our center, we believe that having such a protocol ready for enrollment would mitigate delays in such crucial moments. We seek to enroll and treat 40 patients over a 3 year period.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All subjects must have a proven fungal infection that is resistant to standard therapy, or to which the patient is significantly intolerant. (Intolerance must include signs of intolerance such as fever, rigors, laboratory abnormalities, as well as subjective symptoms). Children are eligible. EXCLUSION CRITERIA: AST, ALT greater than 10x the upper limit of normal Previous hypersensitivity to azole antifungals Concomitant Rifampin, carbamazepine, or barbiturates or greater than 3 days of such drugs in the 14 days prior to treatment with voriconazole
Total Enrollment: 40
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010150; 01-I-0150
Study Start Date: April 11, 2001
Record last reviewed: March 28, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015665
Other Mycoses Studies:
1. An Open Label, Non-comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
2. PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections
3. Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients with Graft vs. Host Disease
4. Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
5. A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
Related Studies:
Other Mycoses Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections
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