COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis
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|ClinicalTrials.gov Identifier: NCT00334412|
Recruitment Status : Completed
First Posted : June 7, 2006
Last Update Posted : July 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Invasive Aspergillosis||Drug: Ambisome Drug: caspofungin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||AmBisome® in Combination With Caspofungin Versus AmBisome® High Dose Regimen for the Treatment of Invasive Aspergillosis in Immunocompromized Patients: Randomized Pilot Study.|
|Study Start Date :||March 2004|
|Study Completion Date :||May 2006|
- To assess efficacy of AmBisome® in combination with caspofungin (Cancidas®) versus AmBisome® high dose regimen in the treatment of Invasive Aspergillosis diagnosed by modified EORTC criteria in immunocompromised patients as probable or proven and deter
- To evaluate and compare the safety and tolerability of the two arms.
- To determine the survival rates and rates of infection relapse at 4 weeks post-treatment for patients treated with each of the two treatment regimens.
- To determine the survival rate at 12 weeks after study entry for patients treated with each of the two treatment regimens.
- To determine and compare the time to favorable response and time to maximal overall response for each of the two treatment regimens.
- To compare the efficacy of each arm versus historical data on conventional amphotericin B and voriconazole for the treatment of Invasive Aspergillosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334412
|Paris, France, 75015|
|Study Director:||Lamine Mahi, MD||Gilead Sciences|