This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A. which are refractory or resistant to standard antifungal therapies; B. for which there are currently no effective therapies; C. with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

Condition	Treatment or Intervention	Phase
Mycoses	Drug: Posaconazole oral suspension	Phase II Phase III

Further Study Details: 

The current clinical trial is designed to provide posaconazole (SCH 56592 to subjects with invasive fungal infections a) which are refractory or resistant to standard antifungal therapies or b) for which there are currently no effective therapies. Subjects with such invasive fungal infections cannot be enrolled in controlled, randomized clinical trials. Secondly, this clinical trial is also designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections who c) have experienced serious or severe toxicities while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy. This clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole (SCH 56592) against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.

This is an open-label, treatment protocol for a multi-center study of posaconazole (SCH 56592) 200mg orally four times daily (QID) while hospitalized followed by posaconazole (SCH 56592) 400mg orally twice daily (BID) on discharge from hospital, in the treatment of invasive fungal infections. Approximately 320 subjects have been enrolled at 160 clinical study centers in the US and worldwide.

Ages Eligible for Study:  13 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Proven or probable invasive fungal infections according to EORTC/MSG criteria.
• IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy.
• Able to take oral medication or take medication via enteral feeding tube.

Exclusion Criteria:

• History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals.
• Concurrent progressive neurological disease (except if due to invasive fungal infection)
• Use of medications that are known to interact with azoles and that may lead to life-threatening side effects: terfenadine, cisapride, ebastine at entry or within 24 hours prior to therapy, or astemizole at entry or within 10 days prior to entry.concentration/efficacy of azole antifungals: rifampin, carbamazepine.
• Females pregnant or nursing.

Alabama
      The Univ. of Alabama at Birmingham, Birmingham,  Alabama,  35294-2030,  United States; Recruiting
Arizona
      Phoenix Children's Hospital, Phoenix,  Arizona,  85116,  United States; Recruiting
California
      Kern Medical Center, Bakersfield,  California,  United States; Recruiting
      Naval Medical Center San Diego, San Diego,  California,  United States; Recruiting
      UCSD Medical Center, San Diego,  California,  92103,  United States; Recruiting
      Harbor-UCLA Research and Education Institute, Torrance,  California,  90502,  United States; Recruiting
      Loma Linda University, Loma Linda,  California,  92354,  United States; Recruiting
      Highland General Hospital, Oakland,  California,  94602,  United States; Recruiting
Colorado
      The Children's Hospital, Denver,  Colorado,  80218,  United States; Recruiting
      Rocky Mountain Cancer Center, Denver,  Colorado,  80218,  United States; Recruiting
Connecticut
      Yale University School of Medicine, New Haven,  Connecticut,  06520-8032,  United States; Recruiting
      Midstate Medical Center, Infectious Dis., Meriden,  Connecticut,  06450,  United States; Recruiting
Florida
      University of Florida - College of Medicine, Gainesville,  Florida,  32610,  United States; Recruiting
      Nemour's Children's Clinic, Jacksonville,  Florida,  32207,  United States; Recruiting
      University of Miami School, Miami,  Florida,  33136,  United States; Recruiting
      Univ. of Florida Health Sciences Center, Gainesville,  Florida,  32610,  United States; Recruiting
      Halifax Medical Center, Daytona Beach,  Florida,  32114,  United States; Recruiting
Georgia
      Emory University, Atlanta,  Georgia,  United States; Recruiting
      Blood and Marrow Transplant Group of Georgia, Atlanta,  Georgia,  30342,  United States; Recruiting
      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States; Recruiting
Hawaii
      The Queen's Physicians, Honolulu,  Hawaii,  96813,  United States; Completed
      Queens Medical Center, Honolulu,  Hawaii,  96813,  United States; Recruiting
Idaho
      St. Alphonsus Regional Medical Center, Boise,  Idaho,  83706,  United States; Recruiting
Illinois
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States; Recruiting
      Rush Presbyterian St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
      Northwestern Memorial Hospital, Chicago,  Illinois,  60611,  United States; Recruiting
      Regional Care Association, Joliet,  Illinois,  60432,  United States; Recruiting
Indiana
      Infectious Diseases of Indiana, Indianapolis,  Indiana,  46202,  United States; Recruiting
Iowa
      The Univerity of Iowa, Iowa City,  Iowa,  52242,  United States; Recruiting
Kansas
      Center of Infectious Disease, Wichita,  Kansas,  67214,  United States; Recruiting
Kentucky
      University of Kentucky Med. Ctr., Lexington,  Kentucky,  40536,  United States; Recruiting
Louisiana
      Ochsner Clinical Foundation, New Orleans,  Louisiana,  United States; Recruiting
Maine
      Eastern Maine Medical Center, Bangor,  Maine,  04401-6612,  United States; Completed
Maryland
      National Institute of Health, Bethesda,  Maryland,  20892,  United States; Recruiting
      University of Maryland, Baltimore,  Maryland,  21201,  United States; Recruiting
      Infectious Dis., National Naval Medical Center, Bethesda,  Maryland,  20889,  United States; Recruiting
      Johns Hopkins Univ. Medical Center, Baltimore,  Maryland,  21231,  United States; Recruiting
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
      New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
      Brigham & Women's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Michigan
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States; Recruiting
      VA Ann Arbor Healthcare System, Ann Arbor,  Michigan,  48105,  United States; Recruiting
      Harper Hospital, Detroit,  Michigan,  48201,  United States; Recruiting
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States; Recruiting
      Mayo Clinic, Rochester,  Minnesota,  60432,  United States; Recruiting
Missouri
      The Children's Mercy Hospital Center, Kansas City,  Missouri,  United States; Recruiting
Nebraska
      University of Nebraska, Omaha,  Nebraska,  United States; Recruiting
New Hampshire
      Dartmouth Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States; Recruiting
New Jersey
      Saint Barnabus Medical Center, Livingston,  New Jersey,  07039,  United States; Recruiting
New York
      Memorial Sloan Kettering Infectious Disease, New York,  New York,  10021,  United States; Completed
      Roswell Park Center Institute, Buffalo,  New York,  14263,  United States; Recruiting
      Memorial Sloan Kettering, New York,  New York,  10021,  United States; Recruiting
      Cornell University Medical College, New York,  New York,  10021,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
      Wake Forest University Health Sciences, Winston Salem,  North Carolina,  27157,  United States; Recruiting
Ohio
      Cleveland Clinic Foundation Infectious Disease, Cleveland,  Ohio,  United States; Completed
      Children's Medical Center, Dayton,  Ohio,  45404,  United States; Recruiting
      University of Cincinnati, College of Medicine, Cincinnati,  Ohio,  45267-0558,  United States; Completed
Oregon
      Oregon Health & Science University, Portland,  Oregon,  97239,  United States; Recruiting
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
      Albert Einstein Medical Center, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
Rhode Island
      Boston Univ., School of Medicine, Div.of Infect. Diseases, Providence,  Rhode Island,  02908,  United States; Recruiting
Tennessee
      Methodist Hospital German, Germantown,  Tennessee,  38138,  United States; Recruiting
      St. Jude Children's Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Texas
      University of Texas MDAnderson Cancer Center, Houston,  Texas,  United States; Recruiting
      Hendrick Medical Center, Abilene,  Texas,  United States; Completed
      University of Texas Health Sciences Center, San Antonio,  Texas,  78229,  United States; Recruiting
      Texas Tech University, Odessa,  Texas,  79763,  United States; Recruiting
      The Forth Worth Clinic, Fort Worth,  Texas,  76104,  United States; Recruiting
      University of Texas, Southwest Medical Center, Dallas,  Texas,  53890-8889,  United States; Recruiting
Utah
      University of Utah (Pediatrics, Infectious Disease), Salt Lake City,  Utah,  84132,  United States; Recruiting
Virginia
      Carilion Infectious Disease, Roanoke,  Virginia,  24016,  United States; Completed
Washington
      Virginia Mason Medical Center, Seattle,  Washington,  98111,  United States; Recruiting
Argentina
      Hospital Francisco J Muniz, Buenos Aires,  Argentina; Recruiting
Australia
      Alfred Hospital, Victoria,  3004,  Australia; Recruiting
Belgium
      Institut Jules Bordet, Brussels,  Belgium; Recruiting
      Heilig Hart Zeikenhuis, Roeselaere,  8800,  Belgium; Recruiting
      University Hospital of Antwerp (UZA), Edegem,  2650,  Belgium; Recruiting
      CHR Citadelle, LIEGE,  4000,  Belgium; Recruiting
      University Hospital Ghent, Gent,  9000,  Belgium; Recruiting
      AZ VUB, Brussles,  1090,  Belgium; Recruiting
Brazil
      Hospital Das Clinicas Da FMUSP, Sao Paulo - SP,  Brazil; Recruiting
      Instituto Nacional Do Cances, Rio de Janiero,  Brazil; Recruiting
Canada
      Hopital Maisonneuve-Rosemont, Montreal,  Canada; Recruiting
      Royal University Hospital, Saskatoon,  Canada; Recruiting
Colombia
      Corporation Para Investigaciones Biologicas CIB, Medellin,  Colombia; Recruiting
France
      Hospital Saint Louis, Paris,  France; Recruiting
      Hopital De La Conception, Marseille,  France; Recruiting
      Hopital De Hautepierre, Strasbourg Cedex,  France; Recruiting
      A.P.H. Paris, Creteil,  France; Recruiting
      APH Paris, Hoptial Necker Enfants Malades, Paris,  75743,  France; Recruiting
Germany
      Klinikum der Johannes Gutenberg-Universitaet Mainz, Mainz,  Germany; Recruiting
      Universitaet Koeln, Koeln,  50931,  Germany; Recruiting
      Klinikum der Ludewig Maximillians, Univ. Muenchen, Muenchen,  Germany; Recruiting
      Studien an Universitatsklinikum Tubingen, Tubingen,  Germany; Recruiting
      Charite Campus Mitte der Humboldt-Univ. Berlin, Berlin,  52621,  Germany; Recruiting
      Klinikum der Universitaet REgensburg, Regensburg,  Germany; Recruiting
      Klinikum der J.W. von Goethe-Universitaet, Frankfrut,  60590,  Germany; Recruiting
      Klinikum Braunschweig - Med. Klinik III, Braunschweig,  38114,  Germany; Recruiting
Greece
      Attikon University Hospital, Athens,  12461,  Greece; Recruiting
Israel
      Sheba Medical Center Infectious Disease, RAMAT-GAN,  52621,  Israel; Recruiting
Mexico
      Hospital De Infectologia, Centro Medico Nacional "La Raza" IMASS, Mexico, D.F.,  Mexico; Completed
      Hospital Universitario "DR. J.E. Gonzalez", Monterrey,  Mexico; Completed
      Centro de Investigaciones Medicas Asociadas, Hermosillo,  Mexico; Completed
Netherlands
      University Hospital Nijmegen St. Radbound, Nijmegen,  6500HB,  Netherlands; Recruiting
      Vrije Universiteit Medisch Centrum, Amsterdam,  1081 HV,  Netherlands; Recruiting
Peru
      Hospital Nacional Cayetano Heredia, San Martin de Porres,  Peru; Recruiting
South Africa
      University Of Cape Town, Dept Of Hematology, Cape Town,  South Africa; Completed
Switzerland
      Basel Kantonsspital, Basel,  Switzerland; Recruiting
      University Hospital Geneva, Geneva,  1211,  Switzerland; Recruiting
      Kantonsspital Aarau, AARAU,  Switzerland; Recruiting
United Kingdom
      Glan Clwyd Hospital, Denbinghshire,  LL185UL,  United Kingdom; Recruiting

Study ID Numbers:  P02095; yes
Record last reviewed:  May 2002
Last Updated:  October 13, 2004
Record first received:  May 1, 2002
ClinicalTrials.gov Identifier:  NCT00034632
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08