This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis
Condition: Candidemia; Invasive Candidiasis
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Intervention: Anidulafungin; Voriconazole
Intervention description: All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin.; Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if <40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if <40 kg body weight).
Intervention MeSH terms: Voriconazole; Anidulafungin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-label; non-comparative study to evaluate short course of IV anidulafungin; followed by oral voriconazole; for tx of candidemia/invasive candidiasis.

Summary:

      The primary objective is to estimate global response rate. Clinical, microbiological and
      global response rates and its 95% confidence intervals will be computed. No hypotheses will
      be tested.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient 18 years of age and older.

          -  If female, must be post-menopausal, surgically sterile or using adequate
             contraception,not lactating, and have a negative urine or blood pregnancy test at
             screening, prior to administration of study medication.

          -  Presence of candidemia (positive blood culture) or invasive candidiasis
             (histopathologic or cytopathologic examination of a needle aspiration or biopsy
             specimen from a normally sterile site excluding mucous membranes showing yeast cells)
             obtained within the prior 96 hours to study entry ((informed consent provided).

          -  Presence of one or more of the following signs and symptoms of acute fungal infection
             within the prior 48 hours to initiation of study treatment:

               -  Fever defined as oral temperature greater than or equal to 38 degrees C (100.4
                  degrees F); rectal or core temperature greater than or equal to 38.6 degrees C
                  (101.4 degrees F), or axillary temperature greater than or equal to 37.5 degrees
                  Celsius (99.5 degrees F). Hypothermia defined as rectal or core temperature less
                  than 36.0 degrees C (96.8 degrees F).

               -  Hypotension (systolic blood pressure [SBP] less than 100 mmHg, or SBP decrease
                  greater than or equal to 30 mm Hg from baseline.

               -  Localized signs and symptoms of inflammation (swelling, heat, erythema or
                  purulence at a site infected with Candida spp.).

          -  Patient is classified in one of following categories based on previous antifungal
             treatment: received less than 48 hours of previous systemic antifungal therapy and no
             more than a single dose of echinocandin therapy prior to study entry; intolerant to
             infusion related toxicities of amphotericin B preparations despite appropriate
             supportive measures or serum creatinine increased by >1.5 mg/dl while receiving
             conventional or lipid amphotericin B therapy; or lack of clinical response and/or
             persistent positive blood culture after at least seven days of systemic antifungal
             treatment with a polyene or fluconazole at an adequate dose.

          -  APACHE II 9 score < 25 at study entry.

          -  Patients willing and able to give informed consent, or have a legally authorized
             representative willing to give informed consent on the patients behalf.

          -  Expected survival (in the opinion of the investigator) greater than 4 days.

        Exclusion Criteria:

          -  Hypersensitivity to anidulafungin, other echinocandins or azoles.

          -  Participation presently or within the last 30 days in a trial with other
             investigational drug(s). Patients on antiretroviral or chemotherapy regimens which
             include an investigational drug may participate provided that there has been no change
             in their therapy during the past 4 weeks and no change in treatment is anticipated
             during study participation.

          -  Chronic refractory neutropenia defined as absolute neutrophils count <500 cells/mm3
             for 28 days prior to the baseline visit.

          -  Confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.

          -  Poor venous access that would preclude IV drug delivery or multiple blood draws.

          -  Prosthetic devices at a suspected site of infection unless the device is removed
             within 24 hours of study entry.

          -  Fungal endophthalmitis confirmed by fundoscopy.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration that may interfere with the interpretation of
             trial results and, in the judgment of the investigator, would make the Patient
             inappropriate for entry into this trial.