1921
Volume 97, Issue 5
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract.

Liposomal amphotericin B is being used increasingly to reduce the burden of kala-azar from the Indian subcontinent. There are studies which have evaluated efficacy and safety of liposomal amphotericin B for visceral leishmaniasis in all age groups. However, the only study that specifically addressed treatment of childhood visceral leishmaniasis did not include all ages or document renal and liver function. We, therefore, felt it was important to reassess the efficacy and safety of single dose liposomal amphotericin B in children and adolescents. A total of 100 parasitologically confirmed visceral leishmaniasis patients aged < 15 years were included in this study. Participants consisted of 65 males and 35 females. All of them had come from the endemic region of Bihar. They were administered one dose intravenous infusion of liposomal amphptericin B at 10 mg/kg body weight. Efficacy was assessed as initial and final cure at 1 and 6 months, respectively, and safety of all participants who were recruited in the study. The initial and final cure rate by per protocol analysis was 100% and 97.9%, respectively. Chills and rigors were the most commonly occurring adverse events (AEs). All the AEs were mild in intensity, and none of the patients experienced any serious AEs. No patients developed nephrotoxicity. Our finding indicates that liposomal amphotericin B at 10 mg/kg body weight is safe and effective in children. Results of our study support the use of single dose liposomal amphotericin B in all age group populations for elimination of kala-azar from the Indian subcontinent.

Loading

Article metrics loading...

The graphs shown below represent data from March 2017
/content/journals/10.4269/ajtmh.17-0094
2017-11-08
2018-12-13
Loading full text...

Full text loading...

/deliver/fulltext/14761645/97/5/tpmd170094.html?itemId=/content/journals/10.4269/ajtmh.17-0094&mimeType=html&fmt=ahah

References

  1. Alvar J, Vélez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M, , 2012. Leishmaniasis worldwide and global estimates of its incidence. PLoS One 7: e35671.[Crossref] [Google Scholar]
  2. Sundar S, Chatterjee M, , 2006. Visceral leishmaniasis—current therapeutic modalities. Indian J Med Res 123: 345352. [Google Scholar]
  3. Zijlstra EE, Musa AM, Khalil EA, el-Hassan IM, el-Hassan AM, , 2003. Post-kala-azar dermal leishmaniasis. Lancet Infect Dis 3: 8798.[Crossref] [Google Scholar]
  4. Thakur CP, Narayan S, Ranjan A, , 2004. Epidemiological, clinical and pharmacological study of antimony-resistant visceral leishmaniasis in Bihar, India. Indian J Med Res 120: 166172. [Google Scholar]
  5. Sundar S, Singh A, Rai M, Prajapati VK, Singh AK, Ostyn B, , Boelaert M, Dujardin JC, Chakravarty J, 2012. Efficacy of miltefosine in the treatment of visceral leishmaniasis in India after a decade of use. Clin Infect Dis 55: 543550.[Crossref] [Google Scholar]
  6. Jamil KM, 2015. Effectiveness study of paromomycin IM injection (PMIM) for the treatment of visceral leishmaniasis (VL) in Bangladesh. PLoS Negl Trop Dis 9: e0004118.[Crossref] [Google Scholar]
  7. Sundar S, Mehta H, Suresh AV, Singh SP, Rai M, Murray HW, , 2004. Amphotericin B treatment for Indian visceral leishmaniasis: conventional versus lipid formulations. Clin Infect Dis 38: 377383.[Crossref] [Google Scholar]
  8. Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW, , 2010. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 362: 504512.[Crossref] [Google Scholar]
  9. Mondal D, Alvar J, Hasnain MG, Hossain MS, Ghosh D, Huda MM, Nabi SG, Sundar S, Matlashewski G, Arana B, , 2014. Efficacy and safety of single-dose liposomal amphotericin B for visceral leishmaniasis in a rural public hospital in Bangladesh: a feasibility study. Lancet Glob Health 2: e51e57.[Crossref] [Google Scholar]
  10. National Cancer Institute Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0. DCTD, NCI, NIH, DHHS. 2006. Available at: http://ctep.cancer.gov. Accessed February 2, 2016.
  11. Health Ministers Committed to Eliminate Kala-azar (media advisory), 2014. New Delhi: WHO Regional Office for South-East Asia. Available at: http://www.searo.who.int/mediacentre/releases/2014/pr1580/en/.
  12. Syriopoulou V, Daikos GL, Theodoridou M, Pavlopoulou I, Manolaki AG, Sereti E, Karamboula A, Papathanasiou D, Xenophon KGS, , 2003. Two doses of a lipid formulation of amphotericin B for the treatment of mediterranean visceral leishmaniasis. Clin Infect Dis 36: 560566. [Google Scholar]
  13. Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW, , 2008. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis 47: 10001006.[Crossref] [Google Scholar]
  14. Sundar S, 2011. Comparison of short-course multidrug treatment with standard therapy for visceral leishmaniasis in India: an open-label, non-inferiority, randomised controlled trial. Lancet 377: 477486.[Crossref] [Google Scholar]
  15. Thakur CP, Kanyok TP, Pandey AK, Sinha GP, Messick C, Olliaro P, , 2000. Treatment of visceral leishmaniasis with injectable paromomycin (aminosidine). An open-label randomized phase-II clinical study. Trans R Soc Trop Med Hyg 94: 432433.[Crossref] [Google Scholar]
  16. Pagliano P, Carannante N, Rossi M, Gramiccia M, Gradoni L, Faella FS, Gaeta GB, , 2005. Visceral leishmaniasis in pregnancy: a case series and a systematic review of the literature. J Antimicrob Chemother 55: 229233.[Crossref] [Google Scholar]
  17. Sundar S, Pandey K, Thakur CP, Jha TK, Rabidas VN, Verma N, Lal CS, Verma D, Alam S, Das P, , 2014. Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, Open-Label Study. PLoS Negl Trop Dis 8: e3169.[Crossref] [Google Scholar]
  18. Sundar S, Jha TK, Thakur CP, Mishra M, Singh VP, Buffels R, , 2003. R Single-dose liposomal amphotericin B in the treatment of visceral leishmaniasis in India: a multicenter study. Clin Infect Dis 37: 800804.[Crossref] [Google Scholar]
  19. Sinha PK, 2010. Effectiveness and safety of liposomal amphotericin b for visceral leishmaniasis under routine program conditions in Bihar, India. Am J Trop Med Hyg 83: 357364.[Crossref] [Google Scholar]
  20. Thakur CP, , 2001. A single high dose treatment of kala-azar with Ambisome (amphotericin B lipid complex): a pilot study. Int J Antimicrob Agents 17: 6770.[Crossref] [Google Scholar]
  21. Sundar S, Agrawal G, Rai M, Makharia MK, Murray HW, , 2001. Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trial. BMJ 323: 419422.[Crossref] [Google Scholar]
  22. Sundar S, Jha TK, Thakur CP, Mishra M, Singh VR, Buffels R, , 2002. Low-dose liposomal amphotericin B in refractory Indian visceral leishmaniasis: a multicenter study. Am J Trop Med Hyg 66: 143146.[Crossref] [Google Scholar]
http://instance.metastore.ingenta.com/content/journals/10.4269/ajtmh.17-0094
Loading
/content/journals/10.4269/ajtmh.17-0094
Loading

Data & Media loading...

  • Received : 08 Feb 2017
  • Accepted : 05 Jul 2017

Most Cited This Month

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error