CANDIDEMIA AND INVASIVE CANDIDIASIS MedDRA version: 9.1 Level: HLT Classification code 10007134 Term: Candida infections
Conditions
Interventions
Trade Name: AMBISOME
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Amphotericin B
CAS Number: 1397-89-3
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
GILEAD SCIENCES S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Success at end of therapy - EOT: The definition of success is (criteria a, b, c and d must be satisfied): a. i) Absence of all clinical signs and symptoms present at baseline and absence of any new signs and symptoms that may be observed during the episode of candidemia OR ii) Alternative explanation for persistent or relapsing clinical signs and symptoms present at baseline or during the episode of candidemia such as clearly detectable bacteria (i.e. positive blood cultures) and eradication for the fungal infection (negative cultures). b. Blood cultures or other normally sterile sites culture have become negative for Candida. c. Infected deep tissue sites have become negative for Candida or all clinical signs of local infection have resolved. d. No systemic antifungal agent, other than the study drug, was administered for the episode of candidemia or invasive candidiasis.;Secondary Objective: Efficacy at the 2nd and 4th week after the end of therapy Safety of the 2 mg/kg/day regimen;Primary end point(s): Success at EOT | — |
Countries
Italy
Outcome results
None listed