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

May 11, 2009 updated by: PETHEMA Foundation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital General de Alicante
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clínico y Provincial de Barcelona
      • Cádiz, Spain
        • Hospital Puerta del Mar
      • Córdoba, Spain
        • Complejo Hospitalario Reina Sofía
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves
      • Huelva, Spain
        • Area Hospitalaria Juan Ramón Jimenez
      • Jerez de la Frontera, Spain
        • Hospital general de Jerez de la Frontera
      • La Coruña, Spain
        • Hospital Juan Canalejo
      • Málaga, Spain
        • Hospital Carlos Haya
      • Málaga, Spain
        • . Hospital Clínico Universitario Virgen de la Victoria
      • Palma de Mallorca, Spain
        • Hospital Son Llatzer
      • Palma de Mallorca, Spain
        • Hospital Son Dureta
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Sevilla, Spain
        • Hospital Universitario Virgen Del Rocio
      • Tarragona, Spain
        • Hospital Universitari de Tarragona Joan XXIII
      • Valencia, Spain
        • Hospital Clinico de Valencia
      • Valencia, Spain
        • Hospital Universitario Dr. Peset
      • Valencia, Spain
        • Hospital la Fe
      • Vigo, Spain
        • Complejo Hospitalario Xeral-Cies
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain
        • Institut Catala d'Oncologia
      • Manresa, Barcelona, Spain
        • Xarxa assistencial de Manresa
    • Castellón
      • Castello, Castellón, Spain
        • Hospital General de Castellon
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain
        • Complejo Hospitalario Universitario de Santiago
    • Tarragona
      • Tortosa, Tarragona, Spain
        • Hospital Verge de la Cinta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosis of AI or CI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Caspofungin
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Collaborators

GTEI
SEMICYUC

Investigators

  • Principal Investigator: Miguel Angel Sanz, Dr, Hospital la Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 13, 2006

First Submitted That Met QC Criteria

October 13, 2006

First Posted (Estimate)

October 16, 2006

Study Record Updates

Last Update Posted (Estimate)

May 13, 2009

Last Update Submitted That Met QC Criteria

May 11, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET-CAS-2003-01
  • PET-CAS-2004-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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