Status:
COMPLETED
Acetato de Caspofungin (Cancidas®) in the Treatment of Fungal Infection
Lead Sponsor:
PETHEMA Foundation
Collaborating Sponsors:
GTEI
SEMICYUC
Conditions:
Candidiasis
Aspergillosis
Eligibility:
All Genders
18+ years
Brief Summary
We wanted to determine the efficacy and the safety of caspofungin acetate (CANCIDAS®) in the treatment of invader fungal infection (IFI) specifically, Invasive Candidiasis (CI) in adults patients with...
Detailed Description
Study post-marketing (observational). It is multicenter and prospective. No masking is used, without control group neither is randomized
Eligibility Criteria
Inclusion
- Female and male with 18 years old at least.
- Diagnosis of AI or CI. It will be based in Clinical History, signs and symptoms that the patient takes, discovery of studies of radiology and results of cultivation and/or studies of anatomopathology positives for Candida spp. or Aspergillus spp.
- Patients with AI, must be refractory to or intolerant of other therapies antifungal used in the hospital.
- Patients with CI, must be or not refractory to or intolerant of other therapies antifungal used in the hospital.
Exclusion
- Patients with diagnosis uncertain based in one or more of next criterions: Cultivation positive for Candida in an only localization (urine, spittle, end/current of catheter; osteomyelitis or endocarditis by Candida without treatment appropriated surgical; infection by Candida of prosthetic material without retired of the same; positive blood cultive for Candida in appearance of vascular prosthesis; allergic lung Aspergillosis; and aspergilloma or aspergillosis eye without treatment appropriated surgical).
- Allergic / hypersensitivity to caspofungin.
- Insufficiency several liver (rate of Chile-Pugh \>9).
- Prediction of survival \<5 days.
- Pregnant or breast feeding.
- Previous Participation of patient in this study.
- Presence of other disease or any condition that it can mix up the interpretation of results or create risks.
- Previous Participation of patient in other clinical study that it involve the administration of a drug in investigation in the 14 days previous to your inclusion in the study or during the administration of caspofungin. We can include patients took with antineoplastic drugs in research whenever at lefts a Investigator Coordinator authorizes it before
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00388167
Start Date
March 1 2004
End Date
February 1 2008
Last Update
May 13 2009
Active Locations (27)
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1
Hospital General de Alicante
Alicante, Alicante, Spain
2
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
3
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona, Spain
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain