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

This study has been completed.
Sponsor:
Collaborators:
GTEI
SEMICYUC
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00388167
First received: October 13, 2006
Last updated: May 11, 2009
Last verified: May 2009
  Purpose

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).


Condition Intervention Phase
Candidiasis
Aspergillosis
Drug: Caspofungin
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Estimated Enrollment: 320
Study Start Date: March 2004
Study Completion Date: February 2008
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diagnosis of AI or CI

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388167

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Institut Català d'Oncología
Hospitalet de Llobregat, Barcelona, Spain
Xarxa assistencial de Manresa
Manresa, Barcelona, Spain
Hospital general de Castellón
Castello, Castellón, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain
Hospital General de Alicante
Alicante, 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 Puerta del Mar
Cádiz, Spain
Complejo Hospitalario Reina Sofía
Córdoba, 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 Juan Canalejo
La Coruña, Spain
Hospital Carlos Haya
Málaga, Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Son Dureta
Palma de Mallorca, Spain
Hospital Son Llàtzer
Palma de Mallorca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Complejo Hospitalario Xeral-Cies
Vigo, Spain
Sponsors and Collaborators
PETHEMA Foundation
GTEI
SEMICYUC
Investigators
Principal Investigator: Miguel Angel Sanz, Dr Hospital La Fe
  More Information

Additional Information:
Publications:
Keating GM, Jarvis B. Caspofungin. Drugs 2001; 61: 1121-1129
Tkacz JS. Glucan biosynthesis in fungi and its inhibition. In: Sutcliff JA, Georgopapadaku NH, eds. Emerging Targets in Antibacterial and Antifungal Chemotherapy. New York: Routledge, Chapman & Hall, 1992; 495-523.
Groll AH, Walsh TJ. Potential new antifungal agents. Curr Opin Infect Dis 1997; 10: 449-458
Scott Hicks P, Dorso K, Gerckens I, et al. Comparative In Vitro Susceptibility of Clinical Trial Isolates to the Echinocandin Antifungal Caspofungin (Cancidas, MK- 0991) (Abstract: 193). 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto (Canada), 2000.
Bernard EM, Ishimaru T, Armstrong D. Low doses of the pneumocandin L-743,872, are effective for prevention and treatment in an animal model of pulmonary aspergillosis (abstract: 106). 36th Interscience Conference on Antimicrobial Agents and Chemotherapy; New Orleans, Louisiana, 1996.
Onishi J, Meinz M, Thompson J, et al. Discovery of novel antifungal (1,3)-beta-Dglucan synthase inhibitors. Antimicrob Agents Chemother 2000; 44: 368-377.
. Stone JA, Holland S, Li S, et al. Effect of hepatic insufficiency on the pharmacokinetics of caspofungin (abstract: 14). 41st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, Illinois, 2001
Stone JA, Holland S, Wickersham P, et al. Drug interaction between caspofungin and tacrolimus (abstract: 13). 41st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, Illinois, 2001.
Maertens J, Raad I, Sable CA, et al. Multicenter, noncomparative study to evaluate safety and efficacy of caspofungin in adults with invasive aspergillosis refractory or intolerant to amphotericin B, amphotericin B lipid formulations, or azoles (abstract). 40th Interscience Conference on Antimicrobial Agents and Chemotherapy; Toronto, Canada, 2000
. Hiemenz J, Raad I, Boogaerts M, et al. Efficacy of caspofungin as salvage therapy for invasive aspergillosis compared to standard therapy in a historical cohort (abstract). Focus on Fungal Infections 11, Washington D.C., USA, 2001.
. Maertens J, Raad I, Petrikkos G, et al. Update of the multicenter, noncomparative study of caspofungin in adults with invasive aspergillosis refractory or intolerant to other antifungal agents: an analysis of 90 patients (abstract). 42th Interscience Conference on Antimicrobial Agents and Chemotherapy; San Diego, California, USA, 2002.

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00388167     History of Changes
Other Study ID Numbers: PET-CAS-2003-01, PET-CAS-2004-01
Study First Received: October 13, 2006
Last Updated: May 11, 2009
Health Authority: Spain: Generalitat Valenciana

Keywords provided by PETHEMA Foundation:
Invader fungal infection (IFI)
Invasive Aspergillosis (AI)
Invasive Candidiasis (CI)
Caspofungin acetate

Additional relevant MeSH terms:
Infection
Candidiasis
Mycoses
Aspergillosis
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Skin Diseases
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014