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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 5, 2004 | ||||
| Last Updated Date | May 17, 2007 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Tolerability. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00076869 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Clinical response | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis | ||||
| Official Title ICMJE | A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of MK0991 in Combination With Amphotericin B, Lipid Formulations of Amphotericin B, or Azoles in the Treatment of Invasive Aspergillus Infection in Adults Who Are Refractory to or Intolerant of Standard Therapy | ||||
| Brief Summary | Invasive aspergillosis is a type of fungal infection typically identified in very sick patients (for example, patients with cancer or who have had a bone marrow or organ transplant). This study will seek to enroll patients (16 years of age or older) with invasive aspergillosis infections (involving organs or deep tissues) who are failing or could not tolerate standard antifungal therapy. Your doctor will make this determination based upon specific study criteria. Patients that fulfill all study criteria will be treated daily with both the investigational drug and another antifungal agent. The choice of the other agent is up to your doctor. This investigational drug is approved for the treatment of invasive aspergillosis by itself. The safety and efficacy of this investigational drug, in combination with other agents is not known. |
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| Detailed Description | The duration of treatment is 12 months. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Aspergillosis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Maertens J, Glasmacher A, Herbrecht R, Thiebaut A, Cordonnier C, Segal BH, Killar J, Taylor A, Kartsonis N, Patterson TF, Aoun M, Caillot D, Sable C; Caspofungin Combination Therapy Study Group. Multicenter, noncomparative study of caspofungin in combination with other antifungals as salvage therapy in adults with invasive aspergillosis. Cancer. 2006 Dec 15;107(12):2888-97. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00076869 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2006_400, Formally-0121FI | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | May 2007 | ||||
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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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