Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

Phase 3

Completed

Conditions: Invasive Candidiasis

Interventions: Drug: Anidulafungin
Drug: Fluconazole
Drug: Voriconazole

Registration Number: NCT00689338

Lead Sponsor: Pfizer

Brief Summary: To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 216

Inclusion Criteria

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

Post-abdominal surgery.
Elderly > 65 years old.
Renal insufficiency / failure / hemodialysis.
Solid tumor.
Solid-organ (liver, kidney, lung, heart) transplant recipients.
Hepatic insufficiency.
Neutropenic including hematology oncology patients.

Exclusion Criteria

Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Anidulafungin	Option to treat with oral azole therapy following treatment with anidulafungin
Treatment Group	Voriconazole	Option to treat with oral azole therapy following treatment with anidulafungin
Treatment Group	Fluconazole	Option to treat with oral azole therapy following treatment with anidulafungin

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Global Treatment Response Success at End of Treatment	End of Treatment (Day 14 to Day 56)	Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)	EOIVT (Day 10 up to Day 42)	Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment	2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)	Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Percentage of Participants With Global Response Success 6 Weeks After End of Treatment	6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)	Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Time to First Negative Blood Culture	Day 1 up to Day 42	Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.
Day 90 Survival	Day 90	Percentage of participants known or assumed to be alive on Day 90.
Time to Successful Intensive Care Unit (ICU) Discharge	Day 1 up to Day 56	Time from start of study medication to successful ICU discharge (by end of treatment \[EOT\]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.