NCT00689338 - Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

216

Conditions

Invasive Candidiasis

Interventions

AnidulafunginDRUG

Anidulafungin Intravenous Administration

FluconazoleDRUG

Oral Administration of Fluconazole

VoriconazoleDRUG

Oral Administration of Voriconazole

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (61)

Outcomes

Primary Outcomes

Percentage of Participants With Global Treatment Response Success at End of Treatment

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 frame: End of Treatment (Day 14 to Day 56)

Secondary Outcomes

Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)

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 frame: EOIVT (Day 10 up to Day 42)

Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment

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 frame: 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)

Percentage of Participants With Global Response Success 6 Weeks After End of Treatment

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).