CRITIC - Treatment of Candidemia and Invasive Candidiasis
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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. In case of success AmBisome® at 2 mg/kg/day should be administered for at least 5 days after the complete resolution of all clinical findings of an active infection or for at least 8 days after the last positive blood culture or culture from a normally sterile site. It is not recommended to declare failure (and therefore change treatment) before giving at least 5 days of antifungal therapy. Failures in patients given less than 5 days of treatment should be well documented (e.g. persistent positive cultures despite catheter removal, clinical deterioration in absence of any explanation other than the fungal infection). Follow-up evaluations will be conducted at 2 and 4 weeks after the end of AmBisome® therapy. At end of treatment (time point for success or failure) patients may be shifted to oral (not intravenous) antifungals at the discretion of the local investigator, once a complete response has been achieved, if secondary prophylaxis is deemed necessary.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 1 AmBisome® 2 mg/kg/day in a unique daily IV administration |
Drug: AmBisome
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
|
Outcome Measures
Primary Outcome Measures
- Success at End of Trial (EOT) - Success is defined as: 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 [Through 4 weeks]
Secondary Outcome Measures
- Efficacy at the 2nd and 4th week after the end of therapy [Through 4th week]
- Safety of the 2 mg/kg/day regimen [Through 4 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients admitted to ICU for all medical reasons that meet the inclusion criteria
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Males or non pregnant females (women of child-bearing potential must have a negative serum or urine pregnancy test at baseline).
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Subjects who are 14 years old or older.
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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.
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Subjects who have clinical evidence of infection AT SOME TIME WITHIN 48 HOURS PRIOR TO
ENROLLMENT, including AT LEAST ONE of the following:
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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).
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systolic blood pressure < 90, or a >30 mm Hg decrease in systolic BP from the subject's normal baseline.
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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:
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Subjects with a history of allergy or intolerance to AmBisome®
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Subjects who have received systemic antifungal therapy within 15 days prior to inclusion in the study
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Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration
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Subjects with an absolute neutrophil count of less than 500/mm3 in the 48 hours before enrolment in the study
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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.
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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)
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Subjects with a severe renal impairment defined by a serum creatinine of more than 2.5 mg/dL.
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Women who are pregnant or breastfeeding.
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Subjects who are unlikely to survive more than 24 hours.
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Subjects who previously participated in this study.
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Subjects who have received within the two weeks before study entry, are receiving or likely to receive any investigational drug (unlicensed new chemical entity).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Gilead Sciences Srl | Milan | Italy | 20146 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Luigi Picaro, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GS-IT-131-0177