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Completed

NCT Number: NCT00388167

Acetato de Caspofungin (Cancidas®) in the Treatment of 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Alicante, Alicante, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caspofungin

Drug

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 and collaborators

Lead sponsor

PETHEMA Foundation

Other

Collaborators

  • GTEI
  • SEMICYUC

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2008
First posted
Oct 16, 2006
Registry last updated
May 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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