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

Condition(s) targeted: Candidiasis; Aspergillosis

Intervention: Caspofungin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: PETHEMA Foundation

Official(s) and/or principal investigator(s):
Miguel Angel Sanz, Dr, Principal Investigator, Affiliation: Hospital La Fe

Overall contact:
Miguel Angel Sanz, Dr, Phone: 34 96 386 27 00, Email: sanz_mig@gva.es

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).

Official 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

Study design: Case-Only, Prospective

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Miguel Angel Sanz, Dr, Phone: 34 96 386 27 00, Email: sanz_mig@gva.es

Hospital general de Jerez de la Frontera, Jerez de la Frontera, Spain; Recruiting
León Angel, Dr
León Angel, Dr, Principal Investigator

Area Hospitalaria Juan Ramón Jimenez, Huelva, Spain; Recruiting
Fernández Antonio, Dr
Fernández Antonio, Dr, Principal Investigator

Hospital General de Alicante, Alicante, Spain; Recruiting
Rivas Concepción
Rivas Concepción, Dr, Principal Investigator

Hospital Clínico y Provincial de Barcelona, Barcelona, Spain; Recruiting
Rovira Montse, Dr
Rovira Montse, Dr, Principal Investigator

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Recruiting
Martino Rodrigo, Dr, Principal Investigator

Hospital vall d'Hebrón, Barcelona, Spain; Recruiting
Font Julià, Dr, Principal Investigator

Hospital Puerta del Mar, Cádiz, Spain; Recruiting
Capote Francisco Javier, Dr
Capote Francisco Javier, Dr, Principal Investigator

Complejo Hospitalario Reina Sofía, Córdoba, Spain; Recruiting
Torres Antonio, Dr
Torres Antonio, DR, Principal Investigator

Hospital Universitario Virgen de las Nieves, Granada, Spain; Recruiting
de Pablos José Mª, Dr, Principal Investigator

Hospital Juan Canalejo, La Coruña, Spain; Recruiting
Deben Guillermo, Dr
Deben Guillermo, Dr, Principal Investigator

. Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain; Recruiting
Gema Ramirez
Ramirez Gema, Dr, Principal Investigator

Hospital Carlos Haya, Málaga, Spain; Recruiting
Cuesta Angeles, Dr
Cuesta Angeles, Dr, Principal Investigator

Hospital Son Dureta, Palma de Mallorca, Spain; Recruiting
Novo Andrés, Dr
Novo Andrés, Dr, Principal Investigator

Hospital Universitario Marqués de Valdecilla, Santander, Spain; Recruiting
Lopez Mónica, Dr
Lopez Mónica, Dr, Principal Investigator

Hospital Universitario Virgen del Rocío, Sevilla, Spain; Recruiting
De Blas José Mª, Dr
De Blas José Mª, Dr, Principal Investigator

Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain; Recruiting
Llorente Andrés, Dr, Principal Investigator

Hospital Clínico de Valencia, Valencia, Spain; Recruiting
Solano Carlos, Dr, Principal Investigator

Hospital La Fe, Valencia, Spain; Recruiting
Sanz Miguel Angel
Sanz Miguel Angel, Dr, Principal Investigator

Hospital Universitario Dr. Peset, Valencia, Spain; Recruiting
Rafecas Javier, Dr
Rafecas Javier, Dr, Principal Investigator

Complejo Hospitalario Xeral-Cies, Vigo, Spain; Recruiting
Poderós Concepción, Dr
Poderós Concepción, Dr, Principal Investigator

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain; Recruiting
Jospe Mª Ribera, Doctor
Ribera Josep Mª, Dr, Principal Investigator

Xarxa assistencial de Manresa, Manresa, Barcelona, Spain; Recruiting
Subirà Maricel, Dr, Principal Investigator

Institut Català d'Oncología, Hospitalet de Llobregat, Barcelona, Spain; Recruiting
Berlanga Juan Antonio, Dr
Berlanga Juan Antonio, Dr, Principal Investigator

Hospital general de Castellón, Castello, Castellón, Spain; Recruiting
García Raimundo, Dr
Garcia Raimundo, Dr, Principal Investigator

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Recruiting
Bello José Luis, Dr
Bello José Luis, Dr, Principal Investigator

Hospital Son Llàtzer, Palma de Mallorca, Palma de Mallorca, Spain; Recruiting
Joan Bargay, Dr
Catalina Forteza, Dr
Joan Bargay, Dr, Principal Investigator

Hospital Verge de la Cinta, Tortosa, Tarragona, Spain; Recruiting
Rodriguez Marta, Dr, Principal Investigator

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Starting date: March 2004
Ending date: February 2008
Last updated: November 26, 2008