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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00388167
Recruitment Status : Completed
First Posted : October 16, 2006
Last Update Posted : May 13, 2009
Sponsor:
Collaborators:
GTEI
SEMICYUC
Information provided by:
PETHEMA Foundation

Study Description
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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).

Condition or disease Intervention/treatment
Candidiasis Aspergillosis Drug: Caspofungin

Detailed Description:
Study post-marketing (observational). It is multicenter and prospective. No masking is used, without control group neither is randomized
Study Design
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Study Type : Observational
Estimated Enrollment : 320 participants
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
Study Start Date : March 2004
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388167


Locations
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Sponsors and Collaborators
PETHEMA Foundation
GTEI
SEMICYUC
Investigators
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Principal Investigator: Miguel Angel Sanz, Dr Hospital La Fe
More Information
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Additional Information:

Publications:
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.
. 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
. 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.

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Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00388167    
Other Study ID Numbers: PET-CAS-2003-01
PET-CAS-2004-01
First Posted: October 16, 2006    Key Record Dates
Last Update Posted: May 13, 2009
Last Verified: May 2009
Keywords provided by PETHEMA Foundation:
Invader fungal infection (IFI)
Invasive Aspergillosis (AI)
Invasive Candidiasis (CI)
Caspofungin acetate
Additional relevant MeSH terms:
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Infection
Candidiasis
Mycoses
Aspergillosis
Caspofungin
 Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action