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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00076869 |
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.
Condition | Intervention | Phase |
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Aspergillosis |
Drug: MK0991, caspofungin acetate Drug: Comparator: amphotericin B Drug: Comparator: lipid formulation of amphotericin B and/or azole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 2006_400, Formally-0121FI |
Study First Received: | February 5, 2004 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00076869 |
Health Authority: | United States: Food and Drug Administration |
Definite or probable Invasive Aspergillosis either refractory or intolerant to prior antifungal treatment. |
Abelcet Amphotericin B Mycoses Clotrimazole Miconazole |
Caspofungin Tioconazole Aspergillosis Liposomal amphotericin B |
Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Antifungal Agents |
Therapeutic Uses Antibiotics, Antifungal Amebicides Pharmacologic Actions |