Candidiasis Clinical Trial
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
Verified date | May 2009 |
Source | PETHEMA Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Generalitat Valenciana |
Study type | Observational |
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).
Status | Completed |
Enrollment | 320 |
Est. completion date | February 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General de Alicante | Alicante | |
Spain | Hospital Germans Trias i Pujol | Badalona | Barcelona |
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 | Hospital general de Castellón | Castello | Castellón |
Spain | Complejo Hospitalario Reina Sofía | Córdoba | |
Spain | Hospital Universitario Virgen de las Nieves | Granada | |
Spain | Institut Català d'Oncología | Hospitalet de Llobregat | Barcelona |
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 Clínico Universitario Virgen de la Victoria | Málaga | |
Spain | Hospital Carlos Haya | Málaga | |
Spain | Xarxa assistencial de Manresa | Manresa | Barcelona |
Spain | Hospital Son Dureta | Palma de Mallorca | |
Spain | Hospital Son Llàtzer | Palma de Mallorca | |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | |
Spain | Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | La Coruña |
Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
Spain | Hospital Universitari de Tarragona Joan XXIII | Tarragona | |
Spain | Hospital Verge de la Cinta | Tortosa | Tarragona |
Spain | Hospital Clínico de Valencia | Valencia | |
Spain | Hospital La Fe | Valencia | |
Spain | Hospital Universitario Dr. Peset | Valencia | |
Spain | Complejo Hospitalario Xeral-Cies | Vigo |
Lead Sponsor | Collaborator |
---|---|
PETHEMA Foundation | GTEI, SEMICYUC |
Spain,
. 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.
. 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2001 Nov 26. — View Citation
Balani SK, Xu X, Arison BH, Silva MV, Gries A, DeLuna FA, Cui D, Kari PH, Ly T, Hop CE, Singh R, Wallace MA, Dean DC, Lin JH, Pearson PG, Baillie TA. Metabolites of caspofungin acetate, a potent antifungal agent, in human plasma and urine. Drug Metab Dispos. 2000 Nov;28(11):1274-8. — View Citation
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. — View Citation
Bartizal K, Gill CJ, Abruzzo GK, Flattery AM, Kong L, Scott PM, Smith JG, Leighton CE, Bouffard A, Dropinski JF, Balkovec J. In vitro preclinical evaluation studies with the echinocandin antifungal MK-0991 (L-743,872). Antimicrob Agents Chemother. 1997 Nov;41(11):2326-32. — View Citation
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.
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. — View Citation
Debono M, Gordee RS. Antibiotics that inhibit fungal cell wall development. Annu Rev Microbiol. 1994;48:471-97. Review. — View Citation
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. — View Citation
Denning DW. Echinocandins and pneumocandins--a new antifungal class with a novel mode of action. J Antimicrob Chemother. 1997 Nov;40(5):611-4. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Groll AH, Walsh TJ. Potential new antifungal agents. Curr Opin Infect Dis 1997; 10: 449-458
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. — View Citation
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. — View Citation
Keating GM, Jarvis B. Caspofungin. Drugs. 2001;61(8):1121-9; discussion 1130-1. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum in: Antimicrob Agents Chemother 1994 Oct;38(10):2516. — View Citation
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
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. — View Citation
Mora-Duarte J, Betts R, Rotstein C, Colombo AL, Thompson-Moya L, Smietana J, Lupinacci R, Sable C, Kartsonis N, Perfect J; Caspofungin Invasive Candidiasis Study Group. Comparison of caspofungin and amphotericin B for invasive candidiasis. N Engl J Med. 2002 Dec 19;347(25):2020-9. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Rex JH, Walsh TJ, Sobel JD, Filler SG, Pappas PG, Dismukes WE, Edwards JE. Reply to Dr. Chandrasekar (Clin Infect Dis 2001; 32:320-1) and Drs. Marr and Boeckh (Clin Infect Dis 2001; 32:321). Clin Infect Dis. 2001 Feb 1;32(3):518-9. — View Citation
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.
Stevens DA, Kan VL, Judson MA, Morrison VA, Dummer S, Denning DW, Bennett JE, Walsh TJ, Patterson TF, Pankey GA. Practice guidelines for diseases caused by Aspergillus. Infectious Diseases Society of America. Clin Infect Dis. 2000 Apr;30(4):696-709. Epub 2000 Apr 20. — View Citation
Stone EA, Fung HB, Kirschenbaum HL. Caspofungin: an echinocandin antifungal agent. Clin Ther. 2002 Mar;24(3):351-77; discussion 329. Review. — View Citation
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.
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. — View Citation
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.
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. — View Citation
Villanueva A, Arathoon EG, Gotuzzo E, Berman RS, DiNubile MJ, Sable CA. A randomized double-blind study of caspofungin versus amphotericin for the treatment of candidal esophagitis. Clin Infect Dis. 2001 Nov 1;33(9):1529-35. Epub 2001 Oct 4. — View Citation
Villanueva A, Gotuzzo E, Arathoon EG, Noriega LM, Kartsonis NA, Lupinacci RJ, Smietana JM, DiNubile MJ, Sable CA. A randomized double-blind study of caspofungin versus fluconazole for the treatment of esophageal candidiasis. Am J Med. 2002 Sep;113(4):294-9. — View Citation
* Note: There are 49 references in all — Click here to view all references
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01982071 -
A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
|
Phase 4 | |
Completed |
NCT02391532 -
Effect of Probiotic Bacteria on Oral Candida in Frail Elderly
|
N/A | |
Completed |
NCT01447407 -
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
|
Phase 1 | |
Not yet recruiting |
NCT00889356 -
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
|
Phase 3 | |
Completed |
NCT00105144 -
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
|
Phase 3 | |
Completed |
NCT00163111 -
A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.
|
Phase 3 | |
Completed |
NCT00138502 -
Funguria in Hospitalized Patients
|
||
Not yet recruiting |
NCT04502277 -
Bioavailability of Flucanazole
|
Early Phase 1 | |
Completed |
NCT03203551 -
Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous.
|
N/A | |
Completed |
NCT05044156 -
Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
|
||
Completed |
NCT01322698 -
Staging Candidiasis in ICU Patients
|
N/A | |
Terminated |
NCT01092832 -
A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
|
Phase 3 | |
Terminated |
NCT00095316 -
Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
|
Phase 3 | |
Completed |
NCT04122560 -
Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration
|
Phase 4 | |
Completed |
NCT02641717 -
Validity of Patient-Collected Wet Mounts
|
N/A | |
Recruiting |
NCT01253954 -
A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China
|
N/A | |
Completed |
NCT00797420 -
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers
|
Phase 1 | |
Completed |
NCT00734539 -
Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
|
Phase 3 | |
Completed |
NCT00001937 -
Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
|
Phase 3 | |
Completed |
NCT02666716 -
Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients
|