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

• Sponsor: PETHEMA Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00388167
• Collaborator: GTEI (Other), SEMICYUC (Other)
• Enrollment: 320
• Locations: 27
• Duration (Months): 47
• Patients Per Site: 11.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	Phase
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

• Study Type: Observational
• Anticipated 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: Mar 1, 2004
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	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

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain
2	Institut Català d'Oncología	Hospitalet de Llobregat	Barcelona	Spain
3	Xarxa assistencial de Manresa	Manresa	Barcelona	Spain
4	Hospital general de Castellón	Castello	Castellón	Spain
5	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	La Coruña	Spain
6	Hospital Verge de la Cinta	Tortosa	Tarragona	Spain
7	Hospital General de Alicante	Alicante		Spain
8	Hospital Clínico y Provincial de Barcelona	Barcelona		Spain
9	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain
10	Hospital vall d'Hebrón	Barcelona		Spain
11	Hospital Puerta del Mar	Cádiz		Spain
12	Complejo Hospitalario Reina Sofía	Córdoba		Spain
13	Hospital Universitario Virgen de las Nieves	Granada		Spain
14	Area Hospitalaria Juan Ramón Jimenez	Huelva		Spain
15	Hospital general de Jerez de la Frontera	Jerez de la Frontera		Spain
16	Hospital Juan Canalejo	La Coruña		Spain
17	. Hospital Clínico Universitario Virgen de la Victoria	Málaga		Spain
18	Hospital Carlos Haya	Málaga		Spain
19	Hospital Son Dureta	Palma de Mallorca		Spain
20	Hospital Son Llàtzer	Palma de Mallorca		Spain
21	Hospital Universitario Marqués de Valdecilla	Santander		Spain
22	Hospital Universitario Virgen del Rocío	Sevilla		Spain
23	Hospital Universitari de Tarragona Joan XXIII	Tarragona		Spain
24	Hospital Clínico de Valencia	Valencia		Spain
25	Hospital La Fe	Valencia		Spain
26	Hospital Universitario Dr. Peset	Valencia		Spain
27	Complejo Hospitalario Xeral-Cies	Vigo		Spain

Sponsors and Collaborators

• PETHEMA Foundation
• GTEI
• SEMICYUC

Investigators

• Principal Investigator: Miguel Angel Sanz, Dr, Hospital La Fe

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

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• . 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
• 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.
• 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.
• Arathoon EG, Gotuzzo E, Noriega LM, Berman RS, DiNubile MJ, Sable CA. Randomized, double-blind, multicenter study of caspofungin versus amphotericin B for treatment of oropharyngeal and esophageal candidiases. Antimicrob Agents Chemother. 2002 Feb;46(2):451-7.
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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.
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• 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.
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• 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.
• Hiemenz JW, Raad II, Maertens JA, Hachem RY, Saah AJ, Sable CA, Chodakewitz JA, Severino ME, Saddier P, Berman RS, Ryan DM, Dinubile MJ, Patterson TF, Denning DW, Walsh TJ. Efficacy of caspofungin as salvage therapy for invasive aspergillosis compared to standard therapy in a historical cohort. Eur J Clin Microbiol Infect Dis. 2010 Nov;29(11):1387-94. doi: 10.1007/s10096-010-1013-0. Epub 2010 Aug 12.
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• 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.
• 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.
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• 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
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• ClinicalTrials.gov Identifier: NCT00388167
• Other Study ID Numbers: PET-CAS-2003-01; PET-CAS-2004-01
• First Posted: Oct 16, 2006
• Last Update Posted: May 13, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: Invader fungal infection (IFI); Invasive Aspergillosis (AI); Invasive Candidiasis (CI); Caspofungin acetate
• Additional relevant MeSH terms: Infections; Candidiasis; Mycoses; Aspergillosis; Caspofungin

Study Results

No Results Posted as of May 13, 2009