CRITIC - Treatment of Candidemia and Invasive Candidiasis

Phase 4

Completed

• Conditions: Candidemia; Invasive Candidiasis
• Interventions: Drug: AmBisome

• Registration Number: NCT00670657
• Lead Sponsor: Gilead Sciences

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-02
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-26
• Last Update Posted: 2009-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AmBisome	AmBisome® 2 mg/kg/day in a unique daily IV administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gilead Sciences Srl; 🇮🇹 Milan, Italy