Liposomal Amphotericin B as Initial Therapy for Invasive Mold Infection: A Randomized Trial Comparing a High–Loading Dose Regimen with Standard Dosing (AmBiLoad Trial)
Background.Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma le...
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| Published in | Clinical infectious diseases Vol. 44; no. 10; pp. 1289 - 1297 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
The University of Chicago Press
15.05.2007
University of Chicago Press Oxford University Press |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Background.Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day, but clinical efficacy data for higher doses are lacking. Methods.In a double-blind trial, patients with proven or probable invasive mold infection were randomized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days, followed by 3 mg/kg per day. The primary end point was favorable (i.e., complete or partial) response at the end of study drug treatment. Survival and safety outcomes were also evaluated. Results.Of 201 patients with confirmed invasive mold infection, 107 received the 3-mg/kg daily dose, and 94 received the 10-mg/kg daily dose. Invasive aspergillosis accounted for 97% of cases. Hematological malignancies were present in 93% of patients, and 73% of patients were neutropenic at baseline. A favorable response was achieved in 50% and 46% of patients in the 3- and 10-mg/kg groups, respectively (difference, 4%; 95% confidence interval, -10% to 18%; P > .05); the respective survival rates at 12 weeks were 72% and 59% (difference, 13%; 95% confidence interval, -0.2% to 26%; P > .05). Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group. Conclusions.In highly immunocompromised patients, the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated, with a response rate of 50% and a 12-week survival rate of 72%. The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity. |
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| AbstractList | Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day, but clinical efficacy data for higher doses are lacking.BACKGROUNDTreatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day, but clinical efficacy data for higher doses are lacking.In a double-blind trial, patients with proven or probable invasive mold infection were randomized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days, followed by 3 mg/kg per day. The primary end point was favorable (i.e., complete or partial) response at the end of study drug treatment. Survival and safety outcomes were also evaluated.METHODSIn a double-blind trial, patients with proven or probable invasive mold infection were randomized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days, followed by 3 mg/kg per day. The primary end point was favorable (i.e., complete or partial) response at the end of study drug treatment. Survival and safety outcomes were also evaluated.Of 201 patients with confirmed invasive mold infection, 107 received the 3-mg/kg daily dose, and 94 received the 10-mg/kg daily dose. Invasive aspergillosis accounted for 97% of cases. Hematological malignancies were present in 93% of patients, and 73% of patients were neutropenic at baseline. A favorable response was achieved in 50% and 46% of patients in the 3- and 10-mg/kg groups, respectively (difference, 4%; 95% confidence interval, -10% to 18%; P>.05); the respective survival rates at 12 weeks were 72% and 59% (difference, 13%; 95% confidence interval, -0.2% to 26%; P>.05). Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group.RESULTSOf 201 patients with confirmed invasive mold infection, 107 received the 3-mg/kg daily dose, and 94 received the 10-mg/kg daily dose. Invasive aspergillosis accounted for 97% of cases. Hematological malignancies were present in 93% of patients, and 73% of patients were neutropenic at baseline. A favorable response was achieved in 50% and 46% of patients in the 3- and 10-mg/kg groups, respectively (difference, 4%; 95% confidence interval, -10% to 18%; P>.05); the respective survival rates at 12 weeks were 72% and 59% (difference, 13%; 95% confidence interval, -0.2% to 26%; P>.05). Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group.In highly immunocompromised patients, the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated, with a response rate of 50% and a 12-week survival rate of 72%. The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity.CONCLUSIONSIn highly immunocompromised patients, the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated, with a response rate of 50% and a 12-week survival rate of 72%. The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity. Background. Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day, but clinical efficacy data for higher doses are lacking. Methods. In a double-blind trial, patients with proven or probable invasive mold infection were randomized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days, followed by 3 mg/kg per day. The primary end point was favorable (i.e., complete or partial) response at the end of study drug treatment. Survival and safety outcomes were also evaluated. Results. Of 201 patients with confirmed invasive mold infection, 107 received the 3-mg/kg daily dose, and 94 received the 10-mg/kg daily dose. Invasive aspergillosis accounted for 97% of cases. Hematological malignancies were present in 93% of patients, and 73% of patients were neutropenic at baseline. A favorable response was achieved in 50% and 46% of patients in the 3- and 10-mg/kg groups, respectively (difference, 4%; 95% confidence interval, -10% to 18%; P > .05); the respective survival rates at 12 weeks were 72% and 59% (difference, 13%; 95% confidence interval, -0.2% to 26%; P > .05). Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group. Conclusions. In highly immunocompromised patients, the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated, with a response rate of 50% and a 12-week survival rate of 72%. The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity. Background. Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day, but clinical efficacy data for higher doses are lacking. Methods. In a double-blind trial, patients with proven or probable invasive mold infection were randomized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days, followed by 3 mg/kg per day. The primary end point was favorable (i.e., complete or partial) response at the end of study drug treatment. Survival and safety outcomes were also evaluated. Results. Of 201 patients with confirmed invasive mold infection, 107 received the 3-mg/kg daily dose, and 94 received the 10-mg/kg daily dose. Invasive aspergillosis accounted for 97% of cases. Hematological malignancies were present in 93% of patients, and 73% of patients were neutropenic at baseline. A favorable response was achieved in 50% and 46% of patients in the 3- and 10-mg/kg groups, respectively (difference, 4%; 95% confidence interval, -10% to 18%; P>.05); the respective survival survival rates at 12 weeks were 72% and 59% (difference, 13%; 95% confidence interval, -0.2% to 26%; P>.05). Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group. Conclusions. In highly immunocompromised patients, the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated, with a response rate of 50% and a 12-week survival rate of 72%. The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity. Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day, but clinical efficacy data for higher doses are lacking. In a double-blind trial, patients with proven or probable invasive mold infection were randomized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days, followed by 3 mg/kg per day. The primary end point was favorable (i.e., complete or partial) response at the end of study drug treatment. Survival and safety outcomes were also evaluated. Of 201 patients with confirmed invasive mold infection, 107 received the 3-mg/kg daily dose, and 94 received the 10-mg/kg daily dose. Invasive aspergillosis accounted for 97% of cases. Hematological malignancies were present in 93% of patients, and 73% of patients were neutropenic at baseline. A favorable response was achieved in 50% and 46% of patients in the 3- and 10-mg/kg groups, respectively (difference, 4%; 95% confidence interval, -10% to 18%; P>.05); the respective survival rates at 12 weeks were 72% and 59% (difference, 13%; 95% confidence interval, -0.2% to 26%; P>.05). Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group. In highly immunocompromised patients, the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated, with a response rate of 50% and a 12-week survival rate of 72%. The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity. Background .Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day, but clinical efficacy data for higher doses are lacking. Methods .In a double-blind trial, patients with proven or probable invasive mold infection were randomized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days, followed by 3 mg/kg per day. The primary end point was favorable (i.e., complete or partial) response at the end of study drug treatment. Survival and safety outcomes were also evaluated. Results .Of 201 patients with confirmed invasive mold infection, 107 received the 3-mg/kg daily dose, and 94 received the 10-mg/kg daily dose. Invasive aspergillosis accounted for 97% of cases. Hematological malignancies were present in 93% of patients, and 73% of patients were neutropenic at baseline. A favorable response was achieved in 50% and 46% of patients in the 3- and 10-mg/kg groups, respectively (difference, 4%; 95% confidence interval, -10% to 18%; P > .05); the respective survival rates at 12 weeks were 72% and 59% (difference, 13%; 95% confidence interval, -0.2% to 26%; P > .05). Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group. Conclusions .In highly immunocompromised patients, the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated, with a response rate of 50% and a 12-week survival rate of 72%. The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity. Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate, but its utility is limited by drug interactions. Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day, but clinical efficacy data for higher doses are lacking. In a double-blind trial, patients with proven or probable invasive mold infection were randomized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days, followed by 3 mg/kg per day. The primary end point was favorable (i.e., complete or partial) response at the end of study drug treatment. Survival and safety outcomes were also evaluated. Of 201 patients with confirmed invasive mold infection, 107 received the 3-mg/kg daily dose, and 94 received the 10-mg/kg daily dose. Invasive aspergillosis accounted for 97% of cases. Hematological malignancies were present in 93% of patients, and 73% of patients were neutropenic at baseline. A favorable response was achieved in 50% and 46% of patients in the 3- and 10-mg/kg groups, respectively (difference, 4%; 95% confidence interval, -10% to 18%; P> .05); the respective survival rates at 12 weeks were 72% and 59% (difference, 13%; 95% confidence interval, -0.2% to 26%; P> .05). Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group. In highly immunocompromised patients, the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated, with a response rate of 50% and a 12-week survival rate of 72%. The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity. |
| Author | Cornely, Oliver A. Herbrecht, Raoul Reichert, Dietmar Bresnik, Mark Heussel, Claus Peter Krause, Stefan W. Vianelli, Nicola Ullmann, Andrew J. Rieger, Christina Thiebaut, Anne Aoun, Mickael Lortholary, Olivier Maertens, Johan Horst, Heinz-August Bouza, Emilio Olavarria, Eduardo Boehme, Angelika Ruhnke, Markus Ebrahimi, Ramin |
| Author_xml | – sequence: 1 givenname: Oliver A. surname: Cornely fullname: Cornely, Oliver A. email: oliver.cornely@uni-koeln.de organization: E-mail: oliver.cornely@uni-koeln.de – sequence: 2 givenname: Johan surname: Maertens fullname: Maertens, Johan – sequence: 3 givenname: Mark surname: Bresnik fullname: Bresnik, Mark – sequence: 4 givenname: Ramin surname: Ebrahimi fullname: Ebrahimi, Ramin – sequence: 5 givenname: Andrew J. surname: Ullmann fullname: Ullmann, Andrew J. – sequence: 6 givenname: Emilio surname: Bouza fullname: Bouza, Emilio – sequence: 7 givenname: Claus Peter surname: Heussel fullname: Heussel, Claus Peter – sequence: 8 givenname: Olivier surname: Lortholary fullname: Lortholary, Olivier – sequence: 9 givenname: Christina surname: Rieger fullname: Rieger, Christina – sequence: 10 givenname: Angelika surname: Boehme fullname: Boehme, Angelika – sequence: 11 givenname: Mickael surname: Aoun fullname: Aoun, Mickael – sequence: 12 givenname: Heinz-August surname: Horst fullname: Horst, Heinz-August – sequence: 13 givenname: Anne surname: Thiebaut fullname: Thiebaut, Anne – sequence: 14 givenname: Markus surname: Ruhnke fullname: Ruhnke, Markus – sequence: 15 givenname: Dietmar surname: Reichert fullname: Reichert, Dietmar – sequence: 16 givenname: Nicola surname: Vianelli fullname: Vianelli, Nicola – sequence: 17 givenname: Stefan W. surname: Krause fullname: Krause, Stefan W. – sequence: 18 givenname: Eduardo surname: Olavarria fullname: Olavarria, Eduardo – sequence: 19 givenname: Raoul surname: Herbrecht fullname: Herbrecht, Raoul |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/17443465$$D View this record in MEDLINE/PubMed |
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| References | Richardson (1_19368255) 2005; 56 (11_38266851) 2002; 34 Adler-Moore (10_11483982) 2002; 49 (20_38275771) 2005; 41 (13_38344223) 1998; 27 Walsh (22_16884630) 2002; 346 (8_38255849) 2000; 31 Singh (3_18619095) 2005; 18 (5_38267680) 2004; 39 Walsh (7_10735692) 1999; 340 Herbrecht (6_17185503) 2002; 347 Walsh (23_18326992) 2004; 351 (2_38269452) 2002; 34 (16_32801319) 1991; 28 Caillot (21_11017795) 2001; 19 Walsh (9_11401628) 2001; 45 Johnson (4_17507735) 2003; 36 Mills (15_15615388) 1994; 86 (17_38275770) 1992; 4 Leenders (14_6204118) 1998; 103 Ng (18_15872980) 1995; 155 17879935 - Clin Infect Dis. 2007 Oct 15;45(8):1106-8; author reply 1108-10 17443466 - Clin Infect Dis. 2007 May 15;44(10):1298-306 17683011 - Clin Infect Dis. 2007 Sep 1;45(5):667-8; author reply 668-9 |
| References_xml | – volume: 351 start-page: 1391 issn: 0028-4793 issue: 14 year: 2004 ident: 23_18326992 publication-title: New England Journal of Medicine doi: 10.1056/NEJMoa040446 – volume: 347 start-page: 408 issn: 0028-4793 issue: 6 year: 2002 ident: 6_17185503 publication-title: New England Journal of Medicine doi: 10.1056/NEJMoa020191 – volume: 86 start-page: 754 issn: 0007-1048 issue: 4 year: 1994 ident: 15_15615388 publication-title: British journal of haematology doi: 10.1111/j.1365-2141.1994.tb04825.x – volume: 31 start-page: 1155 issn: 1058-4838 issue: 5 year: 2000 ident: 8_38255849 publication-title: Clinical Infectious Diseases doi: 10.1086/317451 – volume: 4 start-page: 232 year: 1992 ident: 17_38275770 publication-title: DRUG INVEST doi: 10.1007/BF03258404 – volume: 155 start-page: 1093 issn: 0003-9926 issue: 10 year: 1995 ident: 18_15872980 publication-title: Archives of Internal Medicine doi: 10.1001/archinte.1995.00430100129015 – volume: 36 start-page: 630 issn: 1058-4838 issue: 5 year: 2003 ident: 4_17507735 publication-title: Clinical Infectious Diseases doi: 10.1086/367933 – volume: 45 start-page: 3487 issn: 0066-4804 issue: 12 year: 2001 ident: 9_11401628 publication-title: Antimicrobial Agents and Chemotherapy doi: 10.1128/AAC.45.12.3487-3496.2001 – volume: 346 start-page: 225 issn: 0028-4793 issue: 4 year: 2002 ident: 22_16884630 publication-title: New England Journal of Medicine doi: 10.1056/NEJM200201243460403 – volume: 340 start-page: 764 issn: 0028-4793 issue: 10 year: 1999 ident: 7_10735692 publication-title: New England Journal of Medicine doi: 10.1056/NEJM199903113401004 – volume: 49 start-page: 21 issn: 0305-7453 issue: 90001 year: 2002 ident: 10_11483982 publication-title: Journal of Antimicrobial Chemotherapy doi: 10.1093/jac/dkf503 – volume: 41 start-page: 377 issn: 1058-4838 year: 2005 ident: 20_38275771 publication-title: Clinical Infectious Diseases doi: 10.1086/430919 – volume: 19 start-page: 253 issn: 0732-183X issue: 1 year: 2001 ident: 21_11017795 publication-title: Journal of Clinical Oncology doi: 10.1200/JCO.2001.19.1.253 – volume: 18 start-page: 44 issn: 0893-8512 issue: 1 year: 2005 ident: 3_18619095 publication-title: Clinical Microbiology Reviews doi: 10.1128/CMR.18.1.44-69.2005 – volume: 34 start-page: 7 issn: 1058-4838 issue: 1 year: 2002 ident: 11_38266851 publication-title: Clinical Infectious Diseases doi: 10.1086/323335 – volume: 34 start-page: 909 issn: 1058-4838 issue: 7 year: 2002 ident: 2_38269452 publication-title: Clinical Infectious Diseases doi: 10.1086/339202 – volume: 103 start-page: 205 issn: 0007-1048 issue: 1 year: 1998 ident: 14_6204118 publication-title: British journal of haematology doi: 10.1046/j.1365-2141.1998.00944.x – volume: 56 start-page: i5 issn: 0305-7453 issue: suppl_1 year: 2005 ident: 1_19368255 publication-title: Journal of Antimicrobial Chemotherapy doi: 10.1093/jac/dki218 – volume: 28 start-page: 73 issn: 0305-7453 issue: suppl_B year: 1991 ident: 16_32801319 publication-title: Journal of Antimicrobial Chemotherapy doi: 10.1093/jac/28.suppl_B.73 – volume: 39 start-page: 1563 issn: 1058-4838 issue: 11 year: 2004 ident: 5_38267680 publication-title: Clinical Infectious Diseases doi: 10.1086/423381 – volume: 27 start-page: 1406 issn: 1058-4838 issue: 6 year: 1998 ident: 13_38344223 publication-title: Clinical Infectious Diseases doi: 10.1086/515033 – reference: 17879935 - Clin Infect Dis. 2007 Oct 15;45(8):1106-8; author reply 1108-10 – reference: 17443466 - Clin Infect Dis. 2007 May 15;44(10):1298-306 – reference: 17683011 - Clin Infect Dis. 2007 Sep 1;45(5):667-8; author reply 668-9 |
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| Snippet | Background.Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival... Background. Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival... Background .Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival... Treatment of invasive mold infection in immunocompromised patients remains challenging. Voriconazole has been shown to have efficacy and survival benefits over... |
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| SubjectTerms | Adolescent Adult Aged Amphotericin B - administration & dosage Amphotericin B - adverse effects Antifungal Agents - administration & dosage Antifungal Agents - adverse effects Antifungals Articles and Commentaries Aspergillosis Aspergillosis - drug therapy Child Child, Preschool Clinical outcomes Clinical trials Dosage Dose-Response Relationship, Drug Double-Blind Method Drug therapy Experimentation Female Fungal infections Human subjects Humans Infections Lung Diseases, Fungal - drug therapy Lung Diseases, Fungal - immunology Male Middle Aged Mold Neutropenia Patients Prospective Studies Review boards Stem cell transplantation Survival rates |
| Title | Liposomal Amphotericin B as Initial Therapy for Invasive Mold Infection: A Randomized Trial Comparing a High–Loading Dose Regimen with Standard Dosing (AmBiLoad Trial) |
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