Status:
COMPLETED
Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
Lead Sponsor:
University of Cologne
Conditions:
Invasive Aspergillosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study investigates the safety and tolerability as well as the efficacy and pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic malignancies and proven or...
Detailed Description
Due to its efficacy and a broad antifungal spectrum against relevant fungal pathogens, lack of cross-resistance to azoles and amphotericin B, documented efficacy against human Aspergillus infections, ...
Eligibility Criteria
Inclusion
- Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.
- Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria
Exclusion
- Concomitant other systemic antifungal agents are not permitted on study.
- Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for \> 4 weeks preceding entry into study
- Prior systemic therapy of ≥ 4 days with any polyene anti-fungal agent within 14 days of study enrollment
- Prior systemic therapy of ≥ 4 days with non-polyenes for the current, documented IFI.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00404092
Start Date
October 1 2006
End Date
October 1 2009
Last Update
July 31 2013
Active Locations (4)
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1
University Hospital Gasthuisberg
Leuven, Belgium, 3000
2
Charité - Campus Benjamin Franklin
Berlin, Germany, 12200
3
Klinikum der Universität zu Köln
Cologne, Germany, 50924
4
Universitätsklinikum Münster
Münster, Germany, 48149