Aspergillosis, Candidiasis
Conditions
Keywords
Invader fungal infection (IFI), Invasive Aspergillosis (AI), Invasive Candidiasis (CI), Caspofungin acetate
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 without neutropenia and Invasive Aspergillosis (AI) in adults patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole).
Detailed description
Study post-marketing (observational). It is multicenter and prospective. No masking is used, without control group neither is randomized
Interventions
DRUGCaspofungin
The patients are treated with 70 mg IV of caspofungin on day 1, followed by 50 mg/day IV during the rest of treatment
Sponsors
GTEI
SEMICYUC
PETHEMA Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Countries
Spain
Outcome results
None listed