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

NCT00388167 | Completed

• 2 other identifiers: PET-CAS-2003-01PET-CAS-2004-01
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 27

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).

Conditions

Candidiasis; Aspergillosis

Keywords

Invader fungal infection (IFI); Invasive Aspergillosis (AI); Invasive Candidiasis (CI); Caspofungin acetate

Study Arms (1)

1

Caspofungin

Drug: Caspofungin

Interventions

Caspofungin DRUG

The patients are treated with 70 mg IV of caspofungin on day 1, followed by 50 mg/day IV during the rest of treatment

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of AI or CI

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PETHEMA Foundation: lead
• GTEI: collaborator
• SEMICYUC: collaborator

Study Sites (27)

Hospital General de Alicante

Alicante, Alicante, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Hospital Clínico y Provincial de Barcelona

Barcelona, Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital vall d'Hebrón

Barcelona, Barcelona, Spain

Location

Institut Català d'Oncología

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Xarxa assistencial de Manresa

Manresa, Barcelona, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital general de Castellón

Castelló, Castellón, Spain

Location

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Location

Complejo Hospitalario Reina Sofía

Córdoba, Córdoba, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Location

Hospital Juan Canalejo

A Coruña, La Coruña, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Location

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Location

Hospital Carlos Haya

Málaga, Málaga, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Palma de Mallorca, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Palma de Mallorca, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Tarragona, Spain

Location

Hospital Verge de la Cinta

Tortosa, Tarragona, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Location

Complejo Hospitalario Xeral-Cies

Vigo, Vigo, Spain

Location

Area Hospitalaria Juan Ramón Jimenez

Huelva, Spain

Location

Hospital general de Jerez de la Frontera

Jerez de la Frontera, Spain

Location

Related Publications (49)

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• Arikan S, Lozano-Chiu M, Paetznick V, Rex JH. In vitro synergy of caspofungin and amphotericin B against Aspergillus and Fusarium spp. Antimicrob Agents Chemother. 2002 Jan;46(1):245-7. doi: 10.1128/AAC.46.1.245-247.2002.

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• Graybill JR, Najvar LK, Luther MF, Fothergill AW. Treatment of murine disseminated candidiasis with L-743,872. Antimicrob Agents Chemother. 1997 Aug;41(8):1775-7. doi: 10.1128/AAC.41.8.1775.

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• Espinel-Ingroff A. Comparison of In vitro activities of the new triazole SCH56592 and the echinocandins MK-0991 (L-743,872) and LY303366 against opportunistic filamentous and dimorphic fungi and yeasts. J Clin Microbiol. 1998 Oct;36(10):2950-6. doi: 10.1128/JCM.36.10.2950-2956.1998.

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• Kurtz MB, Heath IB, Marrinan J, Dreikorn S, Onishi J, Douglas C. Morphological effects of lipopeptides against Aspergillus fumigatus correlate with activities against (1,3)-beta-D-glucan synthase. Antimicrob Agents Chemother. 1994 Jul;38(7):1480-9. doi: 10.1128/AAC.38.7.1480.

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• Arikan S, Lozano-Chiu M, Paetznick V, Rex JH. In vitro susceptibility testing methods for caspofungin against Aspergillus and Fusarium isolates. Antimicrob Agents Chemother. 2001 Jan;45(1):327-30. doi: 10.1128/AAC.45.1.327-330.2001.

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• Bowman JC, Hicks PS, Kurtz MB, Rosen H, Schmatz DM, Liberator PA, Douglas CM. The antifungal echinocandin caspofungin acetate kills growing cells of Aspergillus fumigatus in vitro. Antimicrob Agents Chemother. 2002 Sep;46(9):3001-12. doi: 10.1128/AAC.46.9.3001-3012.2002.

  PMID: 12183260 BACKGROUND

• Pfaller MA, Marco F, Messer SA, Jones RN. In vitro activity of two echinocandin derivatives, LY303366 and MK-0991 (L-743,792), against clinical isolates of Aspergillus, Fusarium, Rhizopus, and other filamentous fungi. Diagn Microbiol Infect Dis. 1998 Apr;30(4):251-5. doi: 10.1016/s0732-8893(97)00246-0.

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• Del Poeta M, Schell WA, Perfect JR. In vitro antifungal activity of pneumocandin L-743,872 against a variety of clinically important molds. Antimicrob Agents Chemother. 1997 Aug;41(8):1835-6. doi: 10.1128/AAC.41.8.1835.

  PMID: 9257774 BACKGROUND

• 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.

  BACKGROUND

• Barchiesi F, Schimizzi AM, Fothergill AW, Scalise G, Rinaldi MG. In vitro activity of the new echinocandin antifungal, MK-0991, against common and uncommon clinical isolates of Candida species. Eur J Clin Microbiol Infect Dis. 1999 Apr;18(4):302-4. doi: 10.1007/pl00015011.

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• Marco F, Pfaller MA, Messer SA, Jones RN. Activity of MK-0991 (L-743,872), a new echinocandin, compared with those of LY303366 and four other antifungal agents tested against blood stream isolates of Candida spp. Diagn Microbiol Infect Dis. 1998 Sep;32(1):33-7. doi: 10.1016/s0732-8893(98)00050-9.

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• Vazquez JA, Lynch M, Boikov D, Sobel JD. In vitro activity of a new pneumocandin antifungal, L-743,872, against azole-susceptible and -resistant Candida species. Antimicrob Agents Chemother. 1997 Jul;41(7):1612-4. doi: 10.1128/AAC.41.7.1612.

  PMID: 9210698 BACKGROUND

• Krishnarao TV, Galgiani JN. Comparison of the in vitro activities of the echinocandin LY303366, the pneumocandin MK-0991, and fluconazole against Candida species and Cryptococcus neoformans. Antimicrob Agents Chemother. 1997 Sep;41(9):1957-60. doi: 10.1128/AAC.41.9.1957.

  PMID: 9303393 BACKGROUND

• Nelson PW, Lozano-Chiu M, Rex JH. In vitro growth-inhibitory activity of pneumocandins L-733,560 and L-743,872 against putatively amphotericin B- and fluconazole-resistant Candida isolates: influence of assay conditions. J Med Vet Mycol. 1997 Jul-Aug;35(4):285-7.

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• Pfaller MA, Messer SA, Gee S, Joly S, Pujol C, Sullivan DJ, Coleman DC, Soll DR. In vitro susceptibilities of Candida dubliniensis isolates tested against the new triazole and echinocandin antifungal agents. J Clin Microbiol. 1999 Mar;37(3):870-2. doi: 10.1128/JCM.37.3.870-872.1999.

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• Douglas CM, D'Ippolito JA, Shei GJ, Meinz M, Onishi J, Marrinan JA, Li W, Abruzzo GK, Flattery A, Bartizal K, Mitchell A, Kurtz MB. Identification of the FKS1 gene of Candida albicans as the essential target of 1,3-beta-D-glucan synthase inhibitors. Antimicrob Agents Chemother. 1997 Nov;41(11):2471-9. doi: 10.1128/AAC.41.11.2471.

  PMID: 9371352 BACKGROUND

• Kurtz MB, Abruzzo G, Flattery A, Bartizal K, Marrinan JA, Li W, Milligan J, Nollstadt K, Douglas CM. Characterization of echinocandin-resistant mutants of Candida albicans: genetic, biochemical, and virulence studies. Infect Immun. 1996 Aug;64(8):3244-51. doi: 10.1128/iai.64.8.3244-3251.1996.

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• Douglas CM, Marrinan JA, Li W, Kurtz MB. A Saccharomyces cerevisiae mutant with echinocandin-resistant 1,3-beta-D-glucan synthase. J Bacteriol. 1994 Sep;176(18):5686-96. doi: 10.1128/jb.176.18.5686-5696.1994.

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• Osherov N, May GS, Albert ND, Kontoyiannis DP. Overexpression of Sbe2p, a Golgi protein, results in resistance to caspofungin in Saccharomyces cerevisiae. Antimicrob Agents Chemother. 2002 Aug;46(8):2462-9. doi: 10.1128/AAC.46.8.2462-2469.2002.

  PMID: 12121919 BACKGROUND

• Abruzzo GK, Flattery AM, Gill CJ, Kong L, Smith JG, Pikounis VB, Balkovec JM, Bouffard AF, Dropinski JF, Rosen H, Kropp H, Bartizal K. Evaluation of the echinocandin antifungal MK-0991 (L-743,872): efficacies in mouse models of disseminated aspergillosis, candidiasis, and cryptococcosis. Antimicrob Agents Chemother. 1997 Nov;41(11):2333-8. doi: 10.1128/AAC.41.11.2333.

  PMID: 9371329 BACKGROUND

• Abruzzo GK, Gill CJ, Flattery AM, Kong L, Leighton C, Smith JG, Pikounis VB, Bartizal K, Rosen H. Efficacy of the echinocandin caspofungin against disseminated aspergillosis and candidiasis in cyclophosphamide-induced immunosuppressed mice. Antimicrob Agents Chemother. 2000 Sep;44(9):2310-8. doi: 10.1128/AAC.44.9.2310-2318.2000.

  PMID: 10952573 BACKGROUND

• 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.

  BACKGROUND

• Graybill JR, Bocanegra R, Luther M, Fothergill A, Rinaldi MJ. Treatment of murine Candida krusei or Candida glabrata infection with L-743,872. Antimicrob Agents Chemother. 1997 Sep;41(9):1937-9. doi: 10.1128/AAC.41.9.1937.

  PMID: 9303388 BACKGROUND

• Graybill JR, Najvar LK, Montalbo EM, Barchiesi FJ, Luther MF, Rinaldi MG. Treatment of histoplasmosis with MK-991 (L-743,872). Antimicrob Agents Chemother. 1998 Jan;42(1):151-3. doi: 10.1128/AAC.42.1.151.

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• Kohler S, Wheat LJ, Connolly P, Schnizlein-Bick C, Durkin M, Smedema M, Goldberg J, Brizendine E. Comparison of the echinocandin caspofungin with amphotericin B for treatment of histoplasmosis following pulmonary challenge in a murine model. Antimicrob Agents Chemother. 2000 Jul;44(7):1850-4. doi: 10.1128/AAC.44.7.1850-1854.2000.

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• Powles MA, Liberator P, Anderson J, Karkhanis Y, Dropinski JF, Bouffard FA, Balkovec JM, Fujioka H, Aikawa M, McFadden D, Schmatz D. Efficacy of MK-991 (L-743,872), a semisynthetic pneumocandin, in murine models of Pneumocystis carinii. Antimicrob Agents Chemother. 1998 Aug;42(8):1985-9. doi: 10.1128/AAC.42.8.1985.

  PMID: 9687394 BACKGROUND

• Onishi J, Meinz M, Thompson J, Curotto J, Dreikorn S, Rosenbach M, Douglas C, Abruzzo G, Flattery A, Kong L, Cabello A, Vicente F, Pelaez F, Diez MT, Martin I, Bills G, Giacobbe R, Dombrowski A, Schwartz R, Morris S, Harris G, Tsipouras A, Wilson K, Kurtz MB. Discovery of novel antifungal (1,3)-beta-D-glucan synthase inhibitors. Antimicrob Agents Chemother. 2000 Feb;44(2):368-77. doi: 10.1128/AAC.44.2.368-377.2000.

  PMID: 10639364 BACKGROUND

• Hajdu R, Thompson R, Sundelof JG, Pelak BA, Bouffard FA, Dropinski JF, Kropp H. Preliminary animal pharmacokinetics of the parenteral antifungal agent MK-0991 (L-743,872). Antimicrob Agents Chemother. 1997 Nov;41(11):2339-44. doi: 10.1128/AAC.41.11.2339.

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• Stone JA, Holland SD, Wickersham PJ, Sterrett A, Schwartz M, Bonfiglio C, Hesney M, Winchell GA, Deutsch PJ, Greenberg H, Hunt TL, Waldman SA. Single- and multiple-dose pharmacokinetics of caspofungin in healthy men. Antimicrob Agents Chemother. 2002 Mar;46(3):739-45. doi: 10.1128/AAC.46.3.739-745.2002.

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  BACKGROUND

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  BACKGROUND

• Ascioglu S, Rex JH, de Pauw B, Bennett JE, Bille J, Crokaert F, Denning DW, Donnelly JP, Edwards JE, Erjavec Z, Fiere D, Lortholary O, Maertens J, Meis JF, Patterson TF, Ritter J, Selleslag D, Shah PM, Stevens DA, Walsh TJ; Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Diseases. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2002 Jan 1;34(1):7-14. doi: 10.1086/323335. Epub 2001 Nov 26.

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Related Links

• Related Info

MeSH Terms

Conditions

Candidiasis; Aspergillosis; Candidiasis, Invasive

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Miguel Angel Sanz, Dr

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 16, 2006
• Study Start: March 1, 2004
• Study Completion: February 1, 2008
• Last Updated: May 13, 2009

Record last verified: 2009-05

Locations

ES (27)