Clinical trial NCT00388167: Acetato de Caspofungin (Cancidas®) in the Treatment of Fungal Infection
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidiasis
Aspergillosis
Keywords: Invader fungal infection (IFI)
Invasive Aspergillosis (AI)
Invasive Candidiasis (CI)
Caspofungin acetate
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
Collaborators: name: GTEI
name: SEMICYUC
First posted: 2006-10-16
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of AI or CI

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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncología
state: Barcelona
city: Manresa
country: Spain
facility: Xarxa assistencial de Manresa
state: Barcelona
city: Castello
country: Spain
facility: Hospital general de Castellón
state: Castellón
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: La Coruña
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital vall d'Hebrón
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Córdoba
country: Spain
facility: Complejo Hospitalario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Area Hospitalaria Juan Ramón Jimenez
city: Jerez de la Frontera
country: Spain
facility: Hospital general de Jerez de la Frontera
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Málaga
country: Spain
facility: . Hospital Clínico Universitario Virgen de la Victoria
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Vigo
country: Spain
facility: Complejo Hospitalario Xeral-Cies
Study officials:
affiliation: Hospital La Fe
name: Miguel Angel Sanz, Dr
role: PRINCIPAL_INVESTIGATOR
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