Eligibility criteria
Condition
Neutropenia
Sex
Females and Males
Age
2-17 years
Inclusion criteria
Show details
Exclusion criteria
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Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
NCT00056381
Last updated on November 9, 2019
About this Study
Anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. This study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia).
NCT00056381
Pfizer
Completed
Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17 | ||
| Official Title ICMJE | Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia | ||
| Brief Summary | Anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. This study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia). | ||
| Detailed Description | Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 1 Phase 2 | ||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
| Condition ICMJE | Neutropenia | ||
| Intervention ICMJE | Drug: Anidulafungin | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Actual Enrollment ICMJE | 25 | ||
| Original Enrollment ICMJE | 24 | ||
| Actual Study Completion Date ICMJE | June 2004 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE |
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 2 Years to 17 Years (Child) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00056381 | ||
| Other Study ID Numbers ICMJE | VER002-12 A8851005 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Vicuron Pharmaceuticals | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | October 2008 | ||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
BY PHONE
Pfizer Clinical Trials Contact Center
1-800-718-1021