NCT00670657

CRITIC - Treatment of Candidemia and Invasive Candidiasis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-05-02
• Last updated: 2009-03-27

Locations

1 site across 1 country: Italy