- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001937
Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
A Phase III, Randomized, Double-Blind, Comparative Trial of FK463 Versus Fluconazole for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoetic Stem Cell Transplant
Fever and infection are serious complications of cancer treatment such as bone marrow transplant, especially when white blood cell counts are low. When the number of white blood cells is below 500, the person has a condition called neutropenia and has a high risk of developing an infection. At the first sign of fever, antibiotics are started. However, antibiotics do not kill fungus germs, and fungal infections may be difficult to treat. Thus, the prevention of fungal infections in this population is important. The only medicine approved for prevention of fungal infections is fluconazole, which prevents some but not all types of such infections. A new antifungal medication called FK463 works against more types of fungal infections than fluconazole does. This study will compare the effectiveness, safety, and tolerance of FK463 as compared with fluconazole.
Eight hundred patients will be enrolled in this study. They will be randomly assigned to receive either fluconazole or FK463. Before the medicine is begun, a physical exam as well as a blood sample, mouth swab, urine sample, and chest x-ray will be done. The fluconazole or FK463 will be administered once a day for one hour into the bloodstream through a catheter in the vein. Blood tests will be taken twice a week. Cultures from the blood, mouth, and urine will be taken throughout the study. X-rays and CT scans will only be taken if a fungal infection is suspected. If fever develops, blood will be drawn to check for fungi. If fever and neutropenia continue for more than 4 days, FK463 or fluconazole will be stopped and a standard medication called amphotericin B will be started.
Both FK463 and fluconazole will be administered until white blood cell count returns to greater than 500 (signifying recovery from neutropenia), or up to 42 days after transplantation. Patients will be evaluated 4 weeks after the medicine is stopped.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Informed consent of the patient or legally authorized representative must be obtained prior to entry.
Verbal assent will be obtained from minors capable of understanding.
Patients may be of either gender. Females of childbearing potential must have a negative pregnancy test obtained within 14 days prior to the first dose of study drug.
Patients greater than or equal to 6 months of age.
Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant;
Any patient undergoing an allogeneic hematopoietic stem cell transplant.
Patients must have sufficient venous access to permit administration of study drug and monitoring of safety variables.
No patients who are pregnant or nursing. Females of childbearing potential must avoid becoming pregnant by abstinence or barrier methods of birth control while receiving antifungal agents.
No patients with moderate or severe liver disease, as defined by:
AST or ALT greater than 5 times upper limit of normal (ULN), OR;
Total bilirubin greater than 2.5 times ULN.
No patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment.
No patients who have received systemic antifungal agents within 72 hours prior to the first dose of study drug.
No patients receiving an autologous transplant for nonhematologic malignancies.
No patients known to be infected with HIV due to the lack of data on drug interaction between highly active antiretroviral therapy (HAART) and FK463.
No patients previously randomized in this study.
No patients with a history of anaphylaxis attributed to azole compounds or the echinocandin class or antifungals.
No patients with a concomitant medical condition, in the opinion of the investigator and/or medical monitor, whose participation may create an unacceptable additional risk for the patient.
No patients receiving another investigational drug other than for the treatment of cancer or supportive care.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
- Slavin MA, Osborne B, Adams R, Levenstein MJ, Schoch HG, Feldman AR, Meyers JD, Bowden RA. Efficacy and safety of fluconazole prophylaxis for fungal infections after marrow transplantation--a prospective, randomized, double-blind study. J Infect Dis. 1995 Jun;171(6):1545-52. doi: 10.1093/infdis/171.6.1545.
- Pannuti C, Gingrich R, Pfaller MA, Kao C, Wenzel RP. Nosocomial pneumonia in patients having bone marrow transplant. Attributable mortality and risk factors. Cancer. 1992 Jun 1;69(11):2653-62. doi: 10.1002/1097-0142(19920601)69:113.0.co;2-8.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Systemic Inflammatory Response Syndrome
- Inflammation
- Bacterial Infections and Mycoses
- Sepsis
- Invasive Fungal Infections
- Infections
- Candidiasis
- Mycoses
- Aspergillosis
- Fungemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Fluconazole
Other Study ID Numbers
- 000014
- 00-C-0014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mycoses
-
Steven B. KleiboekerNational Institute of Allergy and Infectious Diseases (NIAID)WithdrawnAdenovirus | Other MycosesUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Fungal Infection Study ForumMerck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Xiamen Amoytop Biotech Co., Ltd.Shanghai Jiao Tong University Affiliated First People's HospitalCompleted
-
Institut National de la Santé Et de la Recherche...UnknownCandidiasisBelgium, France, Italy, Netherlands, Spain
-
PfizerVicuron PharmaceuticalsCompleted
-
Daniel BenjaminEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedFluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams BirthweightCandidiasisUnited States
-
Merck Sharp & Dohme LLCCompleted
Clinical Trials on Fluconazole
-
AstraZenecaCompletedAsthmaUnited States, Canada, Denmark, France, Italy, Sweden, United Kingdom, Belgium, Taiwan, Brazil, Poland, Russian Federation, Spain, Germany, Argentina, Colombia, Mexico
-
National Hospital for Tropical Diseases, Hanoi,...Centers for Disease Control and Prevention; Hospital for Tropical Diseases,...UnknownHIV/AIDS | Mycosis Fungoides | Cryptococcosis | Cryptococcal Meningitis | Opportunistic Infections, HIV Related | Mycosis; OpportunisticVietnam
-
Radboud University Medical CenterSt. Antonius HospitalCompletedObesity | Candidiasis | Invasive Fungal Infections | FluconazoleNetherlands
-
BayerCompletedPharmacology, ClinicalGermany
-
Daniel BenjaminPediatric Pharmacology Research Units NetworkCompletedCandidiasisUnited States
-
PfizerCompleted
-
Anders Rane, MD, PhD, Senior professorKarolinska University HospitalCompletedBacterial Infections and Mycoses | Ductus Arteriosis, PatentSweden
-
Makerere UniversityGilead Sciences; University of MinnesotaRecruitingCryptococcal MeningitisUganda
-
F2G Biotech GmbHThe Clinical Trials Centre Cologne; Klinik für Hämatologie, Aachen; Medizinische...Withdrawn
-
Benha UniversityRecruiting