Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis
NCT ID: NCT00391014
Last Updated: 2009-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2006-01-31
2009-04-30
Brief Summary
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Detailed Description
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The Nebulized Liposomal Amphotericin B (Ambisome) prophylaxis against IPA has shown good tolerance, safety and efficacy in lung transplant recipients.
Extrapolating the results obtained in lung transplant recipients, we get the conclusion that it would be essential to study safety and tolerance of nebulized AMBISOME in the group of patients with different peculiarities, mucositis secondary to chemotherapy, and high incidence of IPA in order to reach the goal of evaluate its efficacy as prophylaxis against IPA in this kind of patients
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
AML patients in induction chemotherapy treatment will received prophylaxis with nebulized liposomal amphotericin B (24 mg/week). It will be maintained during the intensification chemotherapy and in periods between cycles.
If patient required ALO-TPH, the prophylaxis should be followed.
liposomal Amphotericine B
AML patients in induction chemotherapy treatment will received prophylaxis with nebulized liposomal amphotericin B (24 mg/week). It will be maintained during the intensification chemotherapy and in periods between cycles.
If patient required ALO-TPH, the prophylaxis should be followed.
Interventions
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liposomal Amphotericine B
AML patients in induction chemotherapy treatment will received prophylaxis with nebulized liposomal amphotericin B (24 mg/week). It will be maintained during the intensification chemotherapy and in periods between cycles.
If patient required ALO-TPH, the prophylaxis should be followed.
Eligibility Criteria
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Inclusion Criteria
* Patients with Acute myeloid Leukemia (AML), that will start induction chemotherapy or those patients submitted to an Allogeneic haematopoietic progenitor cell transplant.
* The patient is \>18 years old.
Exclusion Criteria
* History of allergy or hypersensitivity to Amphotericin B.
* Patient with intellectual deficit or patients with psychological alterations that make impossible the trial understanding.
* Pregnancy or breastfeeding.
* Patient has received other investigational drug or non traded product within 30 days before trial beginning.
* Patient is enrolled in another clinical research study or/and is receiving an investigational agent for any reason.
* Patient had major surgery within 4 weeks before enrollment.
18 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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pethema
Principal Investigators
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Ruiz Isabel, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Vall d'Hebron
Rovira Montserrat, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Hospital Universitario la Fe
Valencia, Valencia, Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Countries
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References
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Denning DW. Invasive aspergillosis. Clin Infect Dis. 1998 Apr;26(4):781-803; quiz 804-5. doi: 10.1086/513943. No abstract available.
Marr KA, Carter RA, Boeckh M, Martin P, Corey L. Invasive aspergillosis in allogeneic stem cell transplant recipients: changes in epidemiology and risk factors. Blood. 2002 Dec 15;100(13):4358-66. doi: 10.1182/blood-2002-05-1496. Epub 2002 Aug 22.
Winston DJ, Maziarz RT, Chandrasekar PH, Lazarus HM, Goldman M, Blumer JL, Leitz GJ, Territo MC. Intravenous and oral itraconazole versus intravenous and oral fluconazole for long-term antifungal prophylaxis in allogeneic hematopoietic stem-cell transplant recipients. A multicenter, randomized trial. Ann Intern Med. 2003 May 6;138(9):705-13. doi: 10.7326/0003-4819-138-9-200305060-00006.
Siwek GT, Dodgson KJ, de Magalhaes-Silverman M, Bartelt LA, Kilborn SB, Hoth PL, Diekema DJ, Pfaller MA. Invasive zygomycosis in hematopoietic stem cell transplant recipients receiving voriconazole prophylaxis. Clin Infect Dis. 2004 Aug 15;39(4):584-7. doi: 10.1086/422723. Epub 2004 Jul 30.
Kramer MR, Denning DW, Marshall SE, Ross DJ, Berry G, Lewiston NJ, Stevens DA, Theodore J. Ulcerative tracheobronchitis after lung transplantation. A new form of invasive aspergillosis. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):552-6. doi: 10.1164/ajrccm/144.3_Pt_1.552.
Yeldandi V, Laghi F, McCabe MA, Larson R, O'Keefe P, Husain A, Montoya A, Garrity ER Jr. Aspergillus and lung transplantation. J Heart Lung Transplant. 1995 Sep-Oct;14(5):883-90.
Westney GE, Kesten S, De Hoyos A, Chapparro C, Winton T, Maurer JR. Aspergillus infection in single and double lung transplant recipients. Transplantation. 1996 Mar 27;61(6):915-9. doi: 10.1097/00007890-199603270-00013.
Cahill BC, Hibbs JR, Savik K, Juni BA, Dosland BM, Edin-Stibbe C, Hertz MI. Aspergillus airway colonization and invasive disease after lung transplantation. Chest. 1997 Nov 5;112(5):1160-4. doi: 10.1378/chest.112.5.1160.
Reichenspurner H, Gamberg P, Nitschke M, Valantine H, Hunt S, Oyer PE, Reitz BA. Significant reduction in the number of fungal infections after lung-, heart-lung, and heart transplantation using aerosolized amphotericin B prophylaxis. Transplant Proc. 1997 Feb-Mar;29(1-2):627-8. doi: 10.1016/s0041-1345(96)00363-6. No abstract available.
Calvo V, Borro JM, Morales P, Morcillo A, Vicente R, Tarrazona V, Paris F. Antifungal prophylaxis during the early postoperative period of lung transplantation. Valencia Lung Transplant Group. Chest. 1999 May;115(5):1301-4. doi: 10.1378/chest.115.5.1301.
Dubois J, Bartter T, Gryn J, Pratter MR. The physiologic effects of inhaled amphotericin B. Chest. 1995 Sep;108(3):750-3. doi: 10.1378/chest.108.3.750.
Schmitt HJ, Bernard EM, Hauser M, Armstrong D. Aerosol amphotericin B is effective for prophylaxis and therapy in a rat model of pulmonary aspergillosis. Antimicrob Agents Chemother. 1988 Nov;32(11):1676-9. doi: 10.1128/AAC.32.11.1676.
Monforte V, Roman A, Gavalda J, Bravo C, Tenorio L, Ferrer A, Maestre J, Morell F. Nebulized amphotericin B prophylaxis for Aspergillus infection in lung transplantation: study of risk factors. J Heart Lung Transplant. 2001 Dec;20(12):1274-81. doi: 10.1016/s1053-2498(01)00364-3.
Monforte V, Roman A, Gavalda J, Lopez R, Pou L, Simo M, Aguade S, Soriano B, Bravo C, Morell F. Nebulized amphotericin B concentration and distribution in the respiratory tract of lung-transplanted patients. Transplantation. 2003 May 15;75(9):1571-4. doi: 10.1097/01.TP.0000054233.60100.7A.
Lambros MP, Bourne DW, Abbas SA, Johnson DL. Disposition of aerosolized liposomal amphotericin B. J Pharm Sci. 1997 Sep;86(9):1066-9. doi: 10.1021/js9604218.
Thomas DA, Myers MA, Wichert B, Schreier H, Gonzalez-Rothi RJ. Acute effects of liposome aerosol inhalation on pulmonary function in healthy human volunteers. Chest. 1991 May;99(5):1268-70. doi: 10.1378/chest.99.5.1268.
Kume H, Yamazaki T, Abe M, Tanuma H, Okudaira M, Okayasu I. Increase in aspergillosis and severe mycotic infection in patients with leukemia and MDS: comparison of the data from the Annual of the Pathological Autopsy Cases in Japan in 1989, 1993 and 1997. Pathol Int. 2003 Nov;53(11):744-50. doi: 10.1046/j.1440-1827.2003.01548.x.
Nosari A, Oreste P, Cairoli R, Montillo M, Carrafiello G, Astolfi A, Muti G, Marbello L, Tedeschi A, Magliano E, Morra E. Invasive aspergillosis in haematological malignancies: clinical findings and management for intensive chemotherapy completion. Am J Hematol. 2001 Dec;68(4):231-6. doi: 10.1002/ajh.1187.
Behre GF, Schwartz S, Lenz K, Ludwig WD, Wandt H, Schilling E, Heinemann V, Link H, Trittin A, Boenisch O, et al. Aerosol amphotericin B inhalations for prevention of invasive pulmonary aspergillosis in neutropenic cancer patients. Ann Hematol. 1995 Dec;71(6):287-91. doi: 10.1007/BF01697981.
Schwartz S, Behre G, Heinemann V, Wandt H, Schilling E, Arning M, Trittin A, Kern WV, Boenisch O, Bosse D, Lenz K, Ludwig WD, Hiddemann W, Siegert W, Beyer J. Aerosolized amphotericin B inhalations as prophylaxis of invasive aspergillus infections during prolonged neutropenia: results of a prospective randomized multicenter trial. Blood. 1999 Jun 1;93(11):3654-61.
Conneally E, Cafferkey MT, Daly PA, Keane CT, McCann SR. Nebulized amphotericin B as prophylaxis against invasive aspergillosis in granulocytopenic patients. Bone Marrow Transplant. 1990 Jun;5(6):403-6.
Myers SE, Devine SM, Topper RL, Ondrey M, Chandler C, O'Toole K, Williams SF, Larson RA, Geller RB. A pilot study of prophylactic aerosolized amphotericin B in patients at risk for prolonged neutropenia. Leuk Lymphoma. 1992 Oct;8(3):229-33. doi: 10.3109/10428199209054909.
Erjavec Z, Woolthuis GM, de Vries-Hospers HG, Sluiter WJ, Daenen SM, de Pauw B, Halie MR. Tolerance and efficacy of Amphotericin B inhalations for prevention of invasive pulmonary aspergillosis in haematological patients. Eur J Clin Microbiol Infect Dis. 1997 May;16(5):364-8. doi: 10.1007/BF01726364.
Hertenstein B, Kern WV, Schmeiser T, Stefanic M, Bunjes D, Wiesneth M, Novotny J, Heimpel H, Arnold R. Low incidence of invasive fungal infections after bone marrow transplantation in patients receiving amphotericin B inhalations during neutropenia. Ann Hematol. 1994 Jan;68(1):21-6. doi: 10.1007/BF01695915.
Related Links
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Spanish association of Haematology
Other Identifiers
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AMBINEB
Identifier Type: -
Identifier Source: secondary_id
2005-000703-34
Identifier Type: -
Identifier Source: org_study_id
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