Status:
COMPLETED
CRITIC - Treatment of Candidemia and Invasive Candidiasis
Lead Sponsor:
Gilead Sciences
Conditions:
Candidemia
Invasive Candidiasis
Eligibility:
All Genders
14+ years
Phase:
PHASE4
Brief 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
Detailed Description
Subjects will be enrolled to receive intravenously AmBisome® at 2 mg/kg/day for a maximum of 4 weeks. Treatment will be discontinued in case of failure, adverse events precluding treatment or success....
Eligibility Criteria
Inclusion
- 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:
- 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).
- systolic blood pressure \< 90, or a \>30 mm Hg decrease in systolic BP from the subject's normal baseline.
- 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
- 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).
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00670657
Start Date
May 1 2007
End Date
January 1 2009
Last Update
March 27 2009
Active Locations (1)
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1
Gilead Sciences Srl
Milan, Italy, 20146