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

This study has been completed.
Sponsor:
Collaborators:
GTEI
SEMICYUC
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00388167
First received: October 13, 2006
Last updated: May 11, 2009
Last verified: May 2009

October 13, 2006
May 11, 2009
March 2004
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Complete list of historical versions of study NCT00388167 on ClinicalTrials.gov Archive Site
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Acetato de Caspofungin (Cancidas®) in the Treatment of Fungal Infection
PROCAS: Study Observational Prospective and Multicenter to Determine the Clinic Effectiveness and the Safety of Caspofungin Acetate (CANCIDAS®) in the Treatment of Invader Fungal Infection

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).

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Diagnosis of AI or CI

  • Candidiasis
  • Aspergillosis
Drug: Caspofungin
The patients are treated with 70 mg IV of caspofungin on day 1, followed by 50 mg/day IV during the rest of treatment
1
Caspofungin
Intervention: Drug: Caspofungin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
February 2008
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00388167
PET-CAS-2003-01, PET-CAS-2004-01
Not Provided
Pethema, pethema
PETHEMA Foundation
  • GTEI
  • SEMICYUC
Principal Investigator: Miguel Angel Sanz, Dr Hospital La Fe
PETHEMA Foundation
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP