Sundar, Shyam ; Chakravarty, J. ; Rai, V. K. ; Agrawal, N. ; Singh, S. P. ; Chauhan, V. ; Murray, Henry W. (2007) Amphotericin B treatment for Indian visceral leishmaniasis: response to 15 daily versus alternate-day infusions Clinical Infectious Diseases, 45 (5). pp. 556-561. ISSN 1058-4838
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Official URL: http://cid.oxfordjournals.org/content/45/5/556
Related URL: http://dx.doi.org/10.1086/520665
Abstract
Background: For patients with Indian visceral leishmaniasis, amphotericin B deoxycholate is usually given as 15 alternate-day infusions of 1 mg/kg over 30 days (total dose, 15 mg/kg); daily treatment with 1 mg/kg for 20 days (total dose, 20 mg/kg) is also used. This study was done to address the unsettled therapeutic questions of administration schedule (alternate-day vs. daily administration) and dose (1 vs. 0.75 mg/kg) and to determine whether the duration of amphotericin B treatment in Bihar, India, can be shortened to 15 days. Methods: To compare alternate-day versus daily administration and 1-mg/kg versus 0.75-mg/kg doses and to determine whether the duration of treatment could be abbreviated, Indian subjects randomly received 15 infusions of 1 mg/kg (group A; 245 patients) or 0.75 mg/kg (group B; 244 patients) on alternate days or 1 mg/kg (group C; 500 patients) or 0.75 mg/kg (group D; 496 patients) daily. Noninferiority testing compared 6-month cure rates using a 5% margin. Results: Overall, 1439 of the 1485 subjects completed treatment and responded. Treatment interruptions (nephrotoxicity) but not infusion-associated reactions or study removals were more common with daily administration. Final cure rates at 6 months were similar: group A, 234 patients (96%; 95% confidence interval [CI], 92%-98%); group B, 225 patients (92%; 95% CI, 88%-95%); group C, 483 patients (97%; 95% CI, 95%-98%); and group D, 476 patients (96%; 95% CI, 94%-97%; P > .05). Conclusions. Provided that the serum creatinine level is repeated once, daily treatment with amphotericin B, 0.75 mg/kg for 15 days (total dose, 11.25 mg/kg), is efficient and effective for visceral leishmaniasis in India.
Item Type: | Article |
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Source: | Copyright of this article belongs to University of Chicago Press. |
ID Code: | 71753 |
Deposited On: | 28 Nov 2011 04:36 |
Last Modified: | 28 Nov 2011 04:36 |
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