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

NCT ID: NCT00388167

Last Updated: 2009-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2008-02-29

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

Conditions

Candidiasis; Aspergillosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Caspofungin

Caspofungin

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GTEI

UNKNOWN

Sponsor Role: collaborator

SEMICYUC

UNKNOWN

Sponsor Role: collaborator

PETHEMA Foundation

OTHER

Sponsor Role: lead

Responsible Party

pethema

Principal Investigators

Miguel Angel Sanz, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital La Fe

Locations

Hospital General de Alicante

Alicante, Alicante, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Clínico y Provincial de Barcelona

Barcelona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital vall d'Hebrón

Barcelona, Barcelona, Spain

Institut Català d'Oncología

L'Hospitalet de Llobregat, Barcelona, Spain

Xarxa assistencial de Manresa

Manresa, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital general de Castellón

Castelló, Castellón, Spain

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Complejo Hospitalario Reina Sofía

Córdoba, Córdoba, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Hospital Juan Canalejo

A Coruña, La Coruña, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital Carlos Haya

Málaga, Málaga, Spain

Hospital Son Dureta

Palma de Mallorca, Palma de Mallorca, Spain

Hospital Son Llàtzer

Palma de Mallorca, Palma de Mallorca, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Tarragona, Spain

Hospital Verge de la Cinta

Tortosa, Tarragona, Spain

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Hospital La Fe

Valencia, Valencia, Spain

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Complejo Hospitalario Xeral-Cies

Vigo, Vigo, Spain

Area Hospitalaria Juan Ramón Jimenez

Huelva, , Spain

Hospital general de Jerez de la Frontera

Jerez de la Frontera, , Spain

Countries

Spain

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Related Info

Other Identifiers

PET-CAS-2004-01

Identifier Type: -

Identifier Source: secondary_id

PET-CAS-2003-01

Identifier Type: -

Identifier Source: org_study_id