Treatment of Candidemia and Invasive Candidiasis

Title:  UARK 2008-12 Phase IV Open-Label, Non-Comparative Trial of IV Anidulafungin followed by Oral AzoleTherapy for the Treatment of Candidemia and Invasive Candidiasis 
Sponsor:  Pfizer 
PI:  Elias Anaissie, MD 
Phase:  IV 
Purpose:  This study will evaluate the effectiveness of the drug using either a shorter duration of 5 days or a longer duration, up to a maximum of 28 days. The decision of a shorter duration will be based on the result of a blood test taken to detect whether the fungus, Candida, is present in your blood during treatment with anidulafungin. The Candida fungus will be present in your blood or tissue before your treatment with this medication is started but the presence of this infection will be checked frequently by your study doctor. If there is no Candida detected in the specimen, the IV treatment with the study medication, anidulafungin, may be stopped and you may receive oral medication to complete 14 days of therapy. 
Eligibility:  You have been asked to take part in a research study because you have an infection caused by a fungus known as Candida. Infection with Candida is diagnosed using a blood test, also known as a blood culture, to determine if you have fungus in your bloodstream. This infection can also be detected in specimens taken from areas of the body known as “tissue” in medical terms. 
  • Your medical chart will be reviewed and your medical history and the medications that you are currently receiving will be noted as well as any medications given for fungal infections within the last 30 days.
  • You will have a physical exam to determine the current signs and symptoms of your infection.
  • An EKG will be performed + 48 prior to baseline to screen for prolonged QT syndromes.
  • Vitals signs, including temperature, blood pressure, heart rate, respiratory rate.
  • Data will be collected to document the status of your health while in the hospital and your ability to be discharged from the hospital;
  • A blood sample will be taken (about 2 teaspoonfuls) to confirm the presence of an infection with the Candida fungus, if needed.
  • You will be asked to give a blood sample (about 2 teaspoonfuls) for routine blood work.
  • If you are a female and able to have children, you will have a blood (about ½ teaspoonful) or urine pregnancy test.
  • A blood sample
Contact:   Nathan Petty
501-526-6990 ext. 2435