Phase II pilot multicenter study on efficacy and safety of liposomal amphotericin B (AmBisome) at 2 mg/kg/day in the treatment of candidemia and invasive candidiasis in nonneutropenic patients - CRITIC

Active, not recruiting

• Conditions: CANDIDEMIA AND INVASIVE CANDIDIASIS; MedDRA version: 9.1Level: HLTClassification code 10007134Term: Candida infections

• Registration Number: EUCTR2007-000607-15-IT
• Lead Sponsor: GILEAD SCIENCES S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-12
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients admitted to ICU with - at least one positive culture isolation of Candida obtained within 96 hours prior to study entry from blood, IV catheters, abdominal drainage, soft tissue infection or any sample obtained by sterile procedure from normally sterile site, excluding urine, feces, sinuses, mucous membranes and BAL -and at least one of the following observed within 48 hours from the first positive culture: - temperature > 38C on 2 occasions at least 4 hours apart or one determination greater than 38.5C (internal, esophageal, timpani and bladder levels) - systolic blood pressure < 90 mmHg, or ³ 30 mmHg decrease in systolic BP from the subjects baseline (the period between obtaining the patient?s written, signed and dated informed consent, and the first study visit) - signs of inflammation from sterile sites ? bone, joint, skin, eye, esophagus, abdomen, excluding patients on artificial ventilation with positive BAL
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. Subjects with a history of allergy or intolerance to AmBisome Subjects who have received systemic antifungal therapy within 15 days prior to inclusion in the study Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome administration Subjects with an absolute neutrophil count of less than 500/mm3 in the 48 hours before enrolment in the study Subjects with a diagnosis of AIDS (positive HIV serology in association with either CD4 cell counts < 200 cells/mm3or history of an opportunistic infection /neoplasm), aplastic anemia, or Chronic Granulomatous Disease. Subjects with moderate or severe liver disease defined as any one or more of the following: Alkaline phosphatase, ALT, AST, or total bilirubin greater than 5 times the ULN (upper limit of normal) Subjects with a severe renal impairment defined by a serum creatinine of more than 2.5 mg/dL. Women who are pregnant or breastfeeding. Subjects who are unlikely to survive more than 24 hours. Subjects who previously participated in this study. Subjects who have received within the two weeks before study entry, are receiving or likely to receive any investigational drug (unlicensed new chemical entity).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified