Documented Candida or Aspergillus Infections in Pediatric Patients
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00082524
First received: May 11, 2004
Last updated: January 21, 2010
Last verified: January 2010
| Tracking Information | |||||
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| First Received Date ICMJE | May 11, 2004 | ||||
| Last Updated Date | January 21, 2010 | ||||
| Start Date ICMJE | May 2004 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s) | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00082524 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Documented Candida or Aspergillus Infections in Pediatric Patients | ||||
| Official Title ICMJE | A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children With Documented Candida or Aspergillus Infections | ||||
| Brief Summary | This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: caspofungin acetate
Duration of Treatment - 7-90 days
Other Name: MK0991 |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Zaoutis TE, Jafri HS, Huang LM, Locatelli F, Barzilai A, Ebell W, Steinbach WJ, Bradley J, Lieberman JM, Hsiao CC, Seibel N, Laws HJ, Gamba M, Petrecz M, Taylor AF, Strohmaier KM, Chow JW, Kartsonis NA, Ngai AL. A prospective, multicenter study of caspofungin for the treatment of documented Candida or Aspergillus infections in pediatric patients. Pediatrics. 2009 Mar;123(3):877-84. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||
| Ages | 3 Months to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00082524 | ||||
| Other Study ID Numbers ICMJE | 2004_100, Formerly-0404CCAI, MK0991-043 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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