CRITIC - Treatment of Candidemia and Invasive Candidiasis - Full Text View

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00670657

Purpose

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	Intervention	Phase
Candidemia Invasive Candidiasis	Drug: AmBisome	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Amphotericin B

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

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 [ Time Frame: Through 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy at the 2nd and 4th week after the end of therapy [ Time Frame: Through 4th week ] [ Designated as safety issue: No ]
Safety of the 2 mg/kg/day regimen [ Time Frame: Through 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	May 2007
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670657

Locations

Italy
Gilead Sciences Srl
Milan, Italy, 20146

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Luigi Picaro

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences ( Luigi Antonio Picaro )
Study ID Numbers:	GS-IT-131-0177
Study First Received:	April 29, 2008
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00670657 History of Changes
Health Authority:	Italy: National Institute of Health

Keywords provided by Gilead Sciences:

candidemia
invasive candidiasis
Ambisome
liposomal amphotericin B

Study placed in the following topic categories:

Abelcet
Anti-Bacterial Agents
Anti-Infective Agents
Amphotericin B

Mycoses
Candidiasis
Antifungal Agents
Liposomal amphotericin B

Additional relevant MeSH terms:

Abelcet
Amphotericin B
Anti-Infective Agents
Antiprotozoal Agents
Candidiasis
Liposomal amphotericin B
Pharmacologic Actions

Mycoses
Anti-Bacterial Agents
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on September 03, 2009