Safety of a weekly high dose of liposomal amphotericin B for prophylaxis of invasive fungal infection in immunocompromised patients: PROPHYSOME Study

International Journal of Antimicrobial Agents

Volumn 31, Issue 2, 2008, Pages 135-141

  Cordonnier, Catherine ^a   Mohty, Mohamad ^b   Faucher, Catherine ^b   Pautas, Cécile ^a   Robin, Marie ^c   Vey, Norbert ^b   Monchecourt, Françoise ^d   Mahi, Lamine ^d   Ribaud, Patricia ^c  

^a HENRI MONDOR HOSPITAL   (France)

^b INSTITUT PAOLI CALMETTES   (France)

^c SAINT LOUIS HOSPITAL   (France)

^d Gilead Sciences   (France)

Author keywords

Antifungal prophylaxis; Invasive fungal infection; Liposomal amphotericin B

Indexed keywords

AMPHOTERICIN B; AMPHOTERICIN B LIPID COMPLEX; ANTINEOPLASTIC AGENT; BUSULFAN; CREATININE; CYCLOPHOSPHAMIDE; CYCLOSPORIN A;

ABDOMINAL PAIN; ACUTE LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; ACUTE MYELOBLASTIC LEUKEMIA; ADULT; ALLOGENEIC STEM CELL TRANSPLANTATION; ANAPHYLACTIC SHOCK; ANTIFUNGAL ACTIVITY; ANURIA; ANXIETY DISORDER; ARTICLE; ASPERGILLOSIS; CHILL; CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; CREATININE BLOOD LEVEL; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; DYSURIA; ELECTROLYTE DISTURBANCE; FEMALE; FEVER; FLUID RETENTION; HOT FLUSH; HUMAN; HYPOKALEMIA; IMMUNE DEFICIENCY; INJECTION SITE REACTION; INTERSTITIAL NEPHRITIS; KIDNEY DISEASE; KIDNEY FAILURE; KIDNEY TUBULE DISORDER; MALE; MULTICENTER STUDY; MYCOSIS; MYELOABLATIVE CONDITIONING; MYELOPROLIFERATIVE DISORDER; NAUSEA; NEPHROTIC SYNDROME; NEPHROTOXICITY; PHASE 2 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RASH; SEPSIS; SIDE EFFECT; THORAX PAIN; TREATMENT OUTCOME; VOMITING;

ADULT; AMPHOTERICIN B; ANTIFUNGAL AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FUNGEMIA; HEMATOLOGIC NEOPLASMS; HUMANS; IMMUNOCOMPROMISED HOST; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; PILOT PROJECTS; PROSPECTIVE STUDIES; SAFETY;

EID: 37549022969     PISSN: 09248579     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijantimicag.2007.10.001     Document Type: Article

References (29)

1. Wald A., Leisenring W., van Burik J.A., and Bowden R.A. Epidemiology of Aspergillus infections in a large cohort of patients undergoing bone marrow transplantation. J Infect Dis 175 (1997) 1459-1466
2. Marr K.A., Carter R.A., Boeckh M., Martin P., and Corey L. Invasive aspergillosis in allogeneic stem cell transplant recipients: changes in epidemiology and risk factors. Blood 100 (2002) 4358-4366
3. Upton A., Kirby K.A., Carpenter P., Boeckh M., and Marr K.A. Invasive aspergillosis following hematopoietic cell transplantation: outcomes and prognostic factors associated with mortality. Clin Infect Dis 44 (2007) 531-540
4. Bow E.J., Loewen R., Cheang M.S., and Schacter B. Invasive fungal disease in adults undergoing remission-induction therapy for acute myeloid leukemia: the pathogenetic role of the antileukemic regimen. Clin Infect Dis 21 (1995) 361-369
5. Cornely O.A., Ullmann A.J., and Karthaus M. Evidence-based assessment of primary antifungal prophylaxis in patients with hematologic malignancies. Blood 101 (2003) 3365-3372
6. Slavin M.A., Osborne B., Adams R., Levenstein M.J., Schoch H.G., Feldman A.R., et al. Efficacy and safety of fluconazole prophylaxis for fungal infections after marrow transplantation-a prospective, randomized, double-blind study. J Infect Dis 171 (1995) 1545-1552
7. Cornely O.A., Maertens J., Winston D.J., Perfect J., Ullmann A.J., Walsh T.J., et al. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N Engl J Med 356 (2007) 348-359
8. Glasmacher A., Prentice A., Gorschlüter M., Engelhart S., Hahn C., Djulbegovic B., et al. Itraconazole prevents invasive fungal infections in neutropenic patients treated for hematologic malignancies: evidence from a meta-analysis of 3,597 patients. J Clin Oncol 21 (2003) 4615-4626
9. Ullmann A.J., Lipton J.H., Vesole D.H., Chandrasekar P., Langston A., Tarantolo S.R., et al. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. N Engl J Med 356 (2007) 335-347
10. van Burik J.A., Ratanatharathorn V., Stepan D.E., Miller C.B., Lipton J.H., Vesole D.H., et al. Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation. Clin Infect Dis 39 (2004) 1407-1416
11. Perfect J.R., Klotman M.E., Gilbert C.C., Crawford D.D., Rosner G.L., Wright K.A., et al. Prophylactic intravenous amphotericin B in neutropenic autologous bone marrow transplant recipients. J Infect Dis 165 (1992) 891-897
12. Wolff S.N., Fay J., Stevens D., Herzig R.H., Pohlman B., Bolwell B., et al. Fluconazole vs low-dose amphotericin B for the prevention of fungal infections in patients undergoing bone marrow transplantation: a study of the North American Marrow Transplant Group. Bone Marrow Transplant 25 (2000) 853-859
13. Karthaus M., Doellmann T., Klimasch T., Elser C., Rosenthal C., Ganser A., et al. Intensive intravenous amphotericin B for prophylaxis of systemic fungal infections. Results of a prospective controlled pilot study in acute leukemia patients. Chemotherapy 46 (2000) 293-302
14. Bow E.J. Long-term antifungal prophylaxis in high-risk hematopoietic stem cell transplant recipients. Med Mycol 43 Suppl. 1 (2005) S277-S287
15. Walsh T.J., Goodman J.L., Pappas P., Bekersky I., Buell D.N., Roden M., et al. Safety, tolerance, and pharmacokinetics of high-dose liposomal amphotericin B (AmBisome) in patients infected with Aspergillus species and other filamentous fungi: maximum tolerated dose study. Antimicrob Agents Chemother 45 (2001) 3487-3496
16. Tollemar J., Hockerstedt K., Ericzon B.G., Sundberg B., and Ringden O. Fungal prophylaxis with AmBisome in liver and bone marrow transplant recipients: results of two randomized double-blind studies. Transplant Proc 26 (1994) 1833
17. Tollemar J., Ringdén O., Andersson S., Sundberg B., Ljungman P., Sparrelid E., et al. Prophylactic use of liposomal amphotericin B (AmBisome) against fungal infections: a randomized trial in bone marrow transplant recipients. Transplant Proc 25 (1993) 1495-1497
18. Tollemar J., Ringden O., Andersson S., Sundberg B., Ljungman P., and Tyden G. Randomized double-blind study of liposomal amphotericin B (Ambisome) prophylaxis of invasive fungal infections in bone marrow transplant recipients. Bone Marrow Transplant 12 (1993) 577-582
19. Kelsey S.M., Goldman J.M., McCann S., Newland A.C., Scarffe J.H., Oppenheim B.A., et al. Liposomal amphotericin (AmBisome) in the prophylaxis of fungal infections in neutropenic patients: a randomised, double-blind, placebo-controlled study. Bone Marrow Transplant 23 (1999) 163-168
20. te Dorsthorst DT, Verweij PE, Meis JF, Mouton JW. Efficacy of one-day versus seven-day AmBisome treatment in a non-neutropenic murine model of invasive aspergillosis. In: 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 30 October-2 November 2004; Washington, DC. Abstract A1873.
21. Gubbins PO, McConnell SA, Amsden JR, Anaissie E. Comparison of liposomal amphotericin B plasma and tissue concentrations following a single large (15 mg/kg) dose or daily 1 mg/kg dosing. In: 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 30 October-2 November 2004; Washington, DC. Abstract A33.
22. Mehta P., Vinks A., Filipovich A., Vaughn G., Fearing D., Sper C., et al. High-dose weekly AmBisome antifungal prophylaxis in pediatric patients undergoing hematopoietic stem cell transplantation: a pharmacokinetic study. Biol Blood Marrow Transplant 12 (2006) 235-240
23. Cancer Therapy Evaluation Program. Common Toxicity Criteria Version 2.0. DCTD, NCI, NIH, DHHS March 1998. Cancer Therapy Evaluation Program; 1998.
24. Ascioglu S., Rex J.H., de Pauw B., Bennett J.E., Bille J., Crokaert F., et al. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis 34 (2002) 7-14
25. Bekersky I., Fielding R.M., Dressler D.E., Lee J.W., Buell D.N., and Walsh T.J. Pharmacokinetics, excretion, and mass balance of liposomal amphotericin B (AmBisome) and amphotericin B deoxycholate in humans. Antimicrob Agents Chemother 46 (2002) 828-833
26. Garcia A., Adler-Moore J.P., and Proffitt R.T. Single-dose AmBisome (Liposomal amphotericin B) as prophylaxis for murine systemic candidiasis and histoplasmosis. Antimicrob Agents Chemother 44 (2000) 2327-2332
27. European Agency for the Evaluation of Medicinal Products. Committee for Proprietary Medicinal Products (CPMP). Points to consider on the clinical evaluation of new agents for invasive fungal infections. London, UK: CPMP; 2003. http://www.emea.eu.int/pdfs/human/ewp/134301en.pdf [accessed 17 October 2007].
28. El-Cheikh J., Faucher C., Fürst S., Duran S., Berger P., Vey N., et al. High-dose weekly liposomal amphotericin B antifungal prophylaxis following reduced-intensity conditioning allogeneic stem cell transplantation. Bone Marrow Transplant 39 (2007) 301-306
29. Andes D. Clinical utility of antifungal pharmacokinetics and pharmacodynamics. Curr Opin Infect Dis 17 (2004) 533-540