Injectable paromomycin for visceral leishmaniasis in India

New England Journal of Medicine

Volumn 356, Issue 25, 2007, Pages 2571-2581

  Sundar, Shyam ^a   Jha, T K ^b   Thakur, Chandreshwar P ^c   Sinha, Prabhat K ^d   Bhattacharya, Sujit K ^d  

^a BANARAS HINDU UNIVERSITY   (India)

^b Kala azar Research Centre   (India)

^c Balaji Utthan Sansthan   (India)

^d RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES   (India)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B; PAROMOMYCIN;

ADOLESCENT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; AUDIOMETRY; BODY WEIGHT; CHILD; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; INDIA; INJECTION SITE PAIN; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MORTALITY; NEPHROTOXICITY; NEUROPATHY; OTOTOXICITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RIGOR; SIDE EFFECT; TREATMENT OUTCOME; VISCERAL LEISHMANIASIS; VOMITING;

EID: 34250717991     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa066536     Document Type: Article

References (29)

1. Desjeux P. Leishmaniasis: current situation and new perspectives. Comp Immunol Microbiol Infect Dis 2004;27:305-18.
2. Sundar S, More DK, Singh MK, et al. Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic. Clin Infect Dis 2000;31:1104-7.
3. Thakur CP, Sinha GP, Pandey AK, et al. Do the diminishing efficacy and increasing toxicity of sodium stibogluconate in the treatment of visceral leishmaniasis in Bihar, India, justify its continued use as a first-line drug? An observational study of 80 cases. Ann Trop Med Parasitol 1998;92:561-9.
4. Ahasan HA, Chowdhury MA, Azhar MA, Rafiqueuddin AK, Azad KA. Deaths in visceral leishmaniasis (Kala-azar) during treatment. Med J Malaysia 1996;51:29-32.
5. Lira R, Sundar S, Makharia A, et al. Evidence that the high incidence of treatment failures in Indian kala-azar is due to the emergence of antimony-resistant strains of Leishmania donovani. J Infect Dis 1999;180:564-7.
6. Sundar S, Singh VP, Sharma S, Makharia MK, Murray HW. Response to interferon-gamma plus pentavalent antimony in Indian visceral leishmaniasis. J Infect Dis 1997;176:1117-9.
7. Thakur CP, Narayan S, Ranjan A. Epidemiological, clinical and pharmacological study of antimony-resistant visceral leishmaniasis in Bihar, India. Indian J Med Res 2004;120:166-72.
8. Das VN, Ranjan A, Bimal S, et al. Magnitude of unresponsiveness to sodium stibogluconate in the treatment of visceral leishmaniasis in Bihar. Natl Med J India 2005;18:131-3.
9. Sundar S, Rai M. Advances in the treatment of leishmaniasis. Curr Opin Infect Dis 2002;15:593-8.
10. Rosenthal E, Marty P. Recent understanding in the treatment of visceral leishmaniasis. J Postgrad Med 2003;49:61-8.
11. Sundar S, Jha TK, Thakur CP, et al. Oral miltefosine for Indian visceral leishmaniasis. N Engl J Med 2002;347:1739-46.
12. Sundar S, Murray HW. Availability of miltefosine for the treatment of kala-azar in India. Bull World Health Organ 2005;83:394-5.
13. Thakur CP, Kanyok TP, Pandey AK, Sinha GP, Messick C, Olliaro P. Treatment of visceral leishmaniasis with injectable paromomycin (aminosidine): an open-label randomized phase-II clinical study. Trans R Soc Trop Med Hyg 2000;94:432-3.
14. Jha TK, Olliaro P, Thakur CP, et al. Randomised controlled trial of aminosidine (paromomycin) v sodium stibogluconate for treating visceral leishmaniasis in North Bihar, India. BMJ 1998;316:1200-5.
15. Cancer Therapy Evaluation Program. Common toxicity criteria. Bethesda, MD: National Cancer Institute, 1998. (Accessed May 25, 2007, at http://ctep.cancer.gov/forms/CTCv20_4-30-992.pdf.)
16. Wingard JR, Kublis P, Lee L, et al. Clinical significance of nephrotoxicity in patients treated with amphotericin B for suspected or proven aspergillosis. Clin Infect Dis 1999;29:1402-7.
17. Walsh TJ, Pappas P, Winston DJ, et al. Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med 2002;346:225-34. [Erratum, N Engl J Med 2007;356:760.]
18. Singh UK, Sinha RK, Sharma VK. Fulminant hepatitis in Kala-azar. Indian J Pediatr 1995;62:571-4.
19. Jha TK, Sundar S, Thakur CP, et al. Miltefosine, an oral agent, for the treatment of Indian visceral leishmaniasis. N Engl J Med 1999;341:1795-800.
20. el Hag IA, Hashim FA, el Toum IA, Homeida M, el Kalifa M, el Hassan AM. Liver morphology and function in visceral leishmaniasis (Kala-azar). J Clin Pathol 1994;47:547-51.
21. Aggarwal P, Wali JP, Chopra P. Liver in kala-azar. Indian J Gastroenterol 1990;9:135-6.
22. Czeizel AE, Rockenbauer M, Olsen J, Sorensen HT. A teratological study of aminoglycoside antibiotic treatment during pregnancy. Scand J Infect Dis 2000;32:309-13.
23. Thakur CP, Kanyok TP, Pandey AK, et al. A prospective randomized, comparative, open-label trial of the safety and efficacy of paromomycin (aminosidine) plus sodium stibogluconate versus sodium stibogluconate alone for the treatment of visceral leishmaniasis. Trans R Soc Trop Med Hyg 2000;94:429-31.
24. Chunge CN, Owate J, Pamba HO, Donno L. Treatment of visceral leishmaniasis in Kenya by aminosidine alone or combined with sodium stibogluconate. Trans R Soc Trop Med Hyg 1990;84:221-5.
25. Chambers HF. The aminoglycosides. In: Brunton LB, Lazo JS, Parker KL, eds. Goodman & Gilman's The pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill, 2006:1155-71.
26. Collin S, Davidson R, Ritmeijer K, et al. Conflict and kala-azar: determinants of adverse outcomes of kala-azar among patients in southern Sudan. Clin Infect Dis 2004;38:612-9.
27. Zijlstra EE, Musa AM, Khalil EA, el-Hassan IM, el-Hassan AM. Post-kala-azar dermal leishmaniasis. Lancet Infect Dis 2003;3:87-98.
28. Sinha PK, Bimal S, Singh SK, Pandey K, Gangopadhyay DN, Bhattacharya SK. Preand post-treatment evaluation of immunological features in Indian visceral leishmaniasis (VL) patients with HIV co-infection. Indian J Med Res 2006;123:197-202.
29. Sundar S, Maurya R, Singh RK, et al. Rapid, noninvasive diagnosis of visceral leishmaniasis in India: comparison of two immunochromatographic strip tests for detection of anti-K39 antibody. J Clin Microbiol 2006;44:251-3.