Clinical Trial: CRITIC - Treatment of Candidemia and Invasive Candidiasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Candidiasi

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 Summary: 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.
Sponsor: Gilead Sciences

Current Primary Outcome: 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 [ Time Frame: Through 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Efficacy at the 2nd and 4th week after the end of therapy [ Time Frame: Through 4th week ]
  • Safety of the 2 mg/kg/day regimen [ Time Frame: Through 4 weeks ]


Original Secondary Outcome: Same as current

Information By: Gilead Sciences

Dates:
Date Received: April 29, 2008
Date Started: May 2007
Date Completion:
Last Updated: March 26, 2009
Last Verified: March 2009