Official Title: “Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole, For Treatment Of Documented Candidemia/Invasive Candidiasis In Critically Ill Patients.”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Anidulafungin
  • 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.
• Drug: Voriconazole
  • 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).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• The primary efficacy endpoint will be a global response rate, which will be determined based on the investigator assessed clinical response and microbiological response at the end of all study therapy (EOT).
  • Time Frame: EOT
    Safety Issue?: No

Secondary Measures

• Global response rate at the end of IV treatment (EIVT) and at Week 2 follow-up visit.
  • Time Frame: EIVT, week 2
    Safety Issue?: No
• Global response rate per type of Candida species isolated.
  • Time Frame: EIVT, week 2
    Safety Issue?: No
• Global response rate per baseline risk factors for candidemia/invasive Candidiasis.
  • Time Frame: EIVT, week 2
    Safety Issue?: Yes
• Global response rate per pre-specified subgroups of interest at EOT (Patients with abdominal surgery, solid organ transplant, renal insufficiency, on chemotherapy, with central venous catheter, neutropenic status and elderly).
  • Time Frame: EIVT, week 2
    Safety Issue?: Yes
• 30-day survival rate.
  • Time Frame: EIVT, week 2
    Safety Issue?: No
• Attributable mortality regarding candidemia/invasive candidiasis status.
  • Time Frame: EIVT, week 2
    Safety Issue?: Yes
• Time to obtaining negative blood or specimen/tissue culture.
  • Time Frame: EIVT, week 2
    Safety Issue?: No
• Global response according the APACHE II score.
  • Time Frame: EIVT, week 2
    Safety Issue?: No
• Length of hospital stay.
  • Time Frame: EIVT, week 2
    Safety Issue?: No
• Incidence of adverse events (AEs) and discontinuations from the study.
  • Time Frame: EIVT, week 2
    Safety Issue?: Yes
• Time to switch to oral voriconazole therapy.
  • Time Frame: EIVT, week 2
    Safety Issue?: No
• Changes from baseline in vital signs and clinical laboratory parameters.
  • Time Frame: EIVT, week 2
    Safety Issue?: Yes
• Length of ICU stay.
  • Time Frame: EIVT, week 2
    Safety Issue?: No

Inclusion Criteria:

• Male or female patient 18 years of age and older.
• Be hospitalized in the ICU or semi-intensive care unit at the study inclusion.
• 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.).
• If a patient has received or is receiving systemic antifungal treatment or prophylaxis, the patient may be enrolled if: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00548262

Study ID Number: A8851015

ClinicalTrials.gov Identifier: NCT00548262

Health Authority: Brazil: Agencia Nacional de Vigilância Sanitária / Conselho Nacional de Ética em Pesquisa

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