Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT00670657
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00670657
Study Brief:
Protocol Section:
NCT00670657