Tracking Information
Start Date ICMJE | November 2008 |
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Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: October 8, 2008) | To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia. [ Time Frame: Duration of the trial ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: September 26, 2008) | To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia [ Time Frame: Duration of the trial ] [ Designated as safety issue: Yes ] |
Change History | Complete list of historical versions of study NCT00761267 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 26, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study To Assess The Safety, Pharmacokinetics, And Evaluate The Response To Anidulafungin When Treating Children With Invasive Candidiasis |
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Official Title ICMJE | A Prospective, Open-Label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidaemia |
Brief Summary | Anidulafungin (an antifungal drug) is relatively safe and the benefits outweigh the adverse effects when used in children diagnosed with invasive candidiasis, including candidemia. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups | 1: Experimental Subjects with documented or highly suspected candida infection will be initiated on therapy. Subjects enrolled on the basis of high suspicion of candida infection are required to have confirmation of candida infection within 96 hours post treatment initiation. Subjects failing to confirm within this time period may be discontinued from study treatment, but will remain in the study for safety follow-up evaluations. Interventions:
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Recruitment Information
Estimated Enrollment ICMJE | 80 | ||||
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Estimated Completion Date | January 2012 | ||||
Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 1 Month to 17 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Canada, France, Greece, Italy, Korea, Republic of, Portugal, Russian Federation, Spain, Taiwan |
Administrative Information
NCT ID ICMJE | NCT00761267 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc. | ||||
Study ID Numbers ICMJE | A8851008 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer |