Back to resultsCRITIC - Treatment of Candidemia and Invasive Candidiasis (CRITIC)
Primary Purpose
Candidemia, Invasive Candidiasis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
AmBisome
Sponsored by
About this trial
This is an interventional treatment trial for Candidemia focused on measuring candidemia, invasive candidiasis, Ambisome, liposomal amphotericin B
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:
- 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 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).
Sites / Locations
- Gilead Sciences Srl
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
AmBisome® 2 mg/kg/day in a unique daily IV administration
Outcomes
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
Secondary Outcome Measures
Efficacy at the 2nd and 4th week after the end of therapy
Safety of the 2 mg/kg/day regimen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00670657
Brief Title
CRITIC - Treatment of Candidemia and Invasive Candidiasis
Acronym
CRITIC
Official Title
CRITIC: Phase II Pilot Multicenter Study on Efficacy and Safety of Liposomal Amphotericin B (AmBisome®) at 2 mg/kg/Day in the Treatment of Candidemia and Invasive Candidiasis in Non-Neutropenic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidemia, Invasive Candidiasis
Keywords
candidemia, invasive candidiasis, Ambisome, liposomal amphotericin B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AmBisome® 2 mg/kg/day in a unique daily IV administration
Intervention Type
Drug
Intervention Name(s)
AmBisome
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Time Frame
Through 4 weeks
Secondary Outcome Measure Information:
Title
Efficacy at the 2nd and 4th week after the end of therapy
Time Frame
Through 4th week
Title
Safety of the 2 mg/kg/day regimen
Time Frame
Through 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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:
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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Picaro
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Gilead Sciences Srl
City
Milan
ZIP/Postal Code
20146
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
CRITIC - Treatment of Candidemia and Invasive Candidiasis
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