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

Completed

• Conditions: Aspergillosis; Candidiasis
• Interventions: Drug: Caspofungin

• Registration Number: NCT00388167
• Lead Sponsor: PETHEMA Foundation

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

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-10-13
• Study First Submitted QC: 2006-10-13
• Study First Posted: 2006-10-16
• Study Completion: 2008-02
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-11
• Last Update Posted: 2009-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Caspofungin	Caspofungin

Trial Locations

Locations (27)

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, La Coruña, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Xarxa assistencial de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Hospital Verge de la Cinta; 🇪🇸 Tortosa, Tarragona, Spain

Hospital general de Castellón; 🇪🇸 Castello, Castellón, Spain

Institut Català d'Oncología; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Clínico y Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital General de Alicante; 🇪🇸 Alicante, Spain

Complejo Hospitalario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Juan Canalejo; 🇪🇸 La Coruña, Spain

Hospital Puerta del Mar; 🇪🇸 Cádiz, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Area Hospitalaria Juan Ramón Jimenez; 🇪🇸 Huelva, Spain

Hospital general de Jerez de la Frontera; 🇪🇸 Jerez de la Frontera, Spain

Hospital Son Dureta; 🇪🇸 Palma de Mallorca, Spain

Hospital Son Llàtzer; 🇪🇸 Palma de Mallorca, Spain

. Hospital Clínico Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Carlos Haya; 🇪🇸 Málaga, Spain

Hospital Universitari de Tarragona Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital Universitario Dr. Peset; 🇪🇸 Valencia, Spain

Complejo Hospitalario Xeral-Cies; 🇪🇸 Vigo, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain