CRITIC - Treatment of Candidemia and Invasive Candidiasis

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients will receive 2mg/kg/day IV daily administration of AmBisome® over 30-60 minutes as a reaction to signs/symptoms and positive Candida culture

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• Patients admitted to ICU for all medical reasons that meet the inclusion criteria

• Males or non pregnant females (women of child-bearing potential must have a negative serum or urine pregnancy test at baseline).

• Subjects who are 14 years old or older.

• Subjects with at least one positive blood culture isolation of a Candida spp. from a specimen or from a normally sterile site (including abdominal catheters), drawn within 96 hours prior to study entry.

• Subjects who have clinical evidence of infection AT SOME TIME WITHIN 48 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:

1. temperature> 38°C on 2 occasions at least 4 hours apart or one determination greater than 38.5°C (internal, at oesophagus, tympani or bladder levels).

2. systolic blood pressure < 90, or a >30 mm Hg decrease in systolic BP from the subject's normal baseline.

3. Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida

• Subjects or their legal representative (but the subject should sign it in any case when able to) must sign a written informed consent form. Written informed consent must be obtained before any study-related procedure is carried out.

Exclusion Criteria:

• 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).