E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CANDIDEMIA AND INVASIVE CANDIDIASIS |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10007134 |
E.1.2 | Term | Candida infections |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Efficacy at the 2nd and 4th week after the end of therapy Safety of the 2 mg/kg/day regimen |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 patients 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 |
|
E.4 | Principal 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). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |