CRITIC - Treatment of Candidemia and Invasive Candidiasis

NCT ID: NCT00670657

Last Updated: 2009-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-01-31

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.

Conditions

Candidemia; Invasive Candidiasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

AmBisome® 2 mg/kg/day in a unique daily IV administration

Group Type: EXPERIMENTAL

AmBisome

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Gilead Sciences

Principal Investigators

Luigi Picaro

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Gilead Sciences Srl

Milan, , Italy

Countries

Italy

Other Identifiers

GS-IT-131-0177

Identifier Type: -

Identifier Source: org_study_id