Acetato de Caspofungin (Cancidas®) in the Treatment of Fungal Infection

PETHEMA Foundation

Status: Completed

Conditions: Candidiasis; Aspergillosis

Treatments: Drug: Caspofungin

Study type: Observational

Funder types: Other

Identifiers

NCT00388167

PET-CAS-2004-01

PET-CAS-2003-01

Details and patient eligibility

About

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).

Full description

Study post-marketing (observational). It is multicenter and prospective. No masking is used, without control group neither is randomized

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 1 patient group

1

Description:

Caspofungin

Treatment:

Drug: Caspofungin