Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment
|ClinicalTrials.gov Identifier: NCT00158730|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 18, 2005
|Condition or disease||Intervention/treatment||Phase|
|Invasive Aspergillosis Other Fungal Infections||Drug: AmBisome||Phase 3|
To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.
Determine and compare the following parameters for the two treatment arms:
- Safety and tolerability
- Survival rates and the rates of infection relapse at 4 weeks Post Treatment.
- Survival rate at 12 weeks after study entry.
- Time to favorable overall response and time to End of Treatment for patients with favorable overall response.
- Cumulative dose of study drug given through End of Treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Study of the Safety and Efficacy of AmBisome Loading Dose Regimen Vs. a Standard AmBisome Regimen for Initial Treatment of Invasive Aspergillosis and Other Filamentous Fungal Infections in Immunocompromised Patients|
|Study Start Date :||April 2003|
|Estimated Study Completion Date :||January 2005|
- Evaluate two regimens determined by overall response rates at end of tx.
- Compare Safety/tolerability; survival rates/rates of infection relapse at 4 wks post tx; survival rate at 12 wks after study entry; TOVR; time to end of tx for patients w/favorable overall response;cumulative dose