CRITIC - Treatment of Candidemia and Invasive Candidiasis

NCT00670657 | Completed Phase 4

• 1 other identifier: GS-IT-131-0177
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Candidemia; Invasive Candidiasis

Keywords

candidemia; invasive candidiasis; Ambisome; liposomal amphotericin B

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Drug: AmBisome

Interventions

AmBisome 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

1

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with a history of allergy or intolerance to AmBisome®
• 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).

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences Srl

Milan, 20146, Italy

Location

MeSH Terms

Conditions

Candidemia; Candidiasis, Invasive

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luigi Picaro

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 2, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: March 27, 2009

Record last verified: 2009-03

Locations

IT (1)