CRITIC - Treatment of Candidemia and Invasive Candidiasis

Candidemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670657
• Other study ID #: GS-IT-131-0177
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2008
• Last updated: March 26, 2009
• Start date: May 2007
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Intervention

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

Locations

Country	Name	City	State
Italy	Gilead Sciences Srl	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Efficacy at the 2nd and 4th week after the end of therapy		Through 4th week	No
Secondary	Safety of the 2 mg/kg/day regimen		Through 4 weeks	No