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Efficacy and tolerability of miltefosine for childhood visceral leishmaniasis in India.
Clin Infect Dis. 2004 Jan 15; 38(2):217-21.CI

Abstract

Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2-11 years) with parasitologically confirmed infection in an open-label clinical trial. Clinical and parasitological parameters were reassessed at the end of treatment and 6 months later. One patient died of intercurrent pneumonia on day 6. The other 79 patients demonstrated no parasites after treatment, had marked clinical improvement, and were deemed initially cured. Three patients had relapse, and 1 patient was lost to follow-up. The final cure rate was 94% for all enrolled patients and 95% for evaluable patients. Side effects included mild-to-moderate vomiting or diarrhea (each in approximately 25% of patients) and mild-to-moderate, transient elevations in the aspartate aminotransferase level during the early treatment phase (in 55%). This trial indicates that miltefosine is as effective and well tolerated in Indian children with VL as in adults and that it can be recommended as the first choice for treatment of childhood VL in India.

Authors+Show Affiliations

Bhattacharya SK
Rajendra Memorial Research Institute of Medical Sciences, Agamkuan, India. JBe9320457@aol.com
Jha TK
No affiliation info available
Sundar S
No affiliation info available
Thakur CP
No affiliation info available
Engel J
No affiliation info available
Sindermann H
No affiliation info available
Junge K
No affiliation info available
Karbwang J
No affiliation info available
Bryceson AD
No affiliation info available
Berman JD
No affiliation info available

MeSH

AnimalsAntiprotozoal AgentsChildChild, PreschoolFemaleHumansLeishmaniasis, VisceralMalePhosphorylcholineTreatment Outcome

Pub Type(s)

Clinical Trial
Controlled Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14699453

Citation

Bhattacharya, Sujit K., et al. "Efficacy and Tolerability of Miltefosine for Childhood Visceral Leishmaniasis in India." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 38, no. 2, 2004, pp. 217-21.
Bhattacharya SK, Jha TK, Sundar S, et al. Efficacy and tolerability of miltefosine for childhood visceral leishmaniasis in India. Clin Infect Dis. 2004;38(2):217-21.
Bhattacharya, S. K., Jha, T. K., Sundar, S., Thakur, C. P., Engel, J., Sindermann, H., Junge, K., Karbwang, J., Bryceson, A. D., & Berman, J. D. (2004). Efficacy and tolerability of miltefosine for childhood visceral leishmaniasis in India. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 38(2), 217-21.
Bhattacharya SK, et al. Efficacy and Tolerability of Miltefosine for Childhood Visceral Leishmaniasis in India. Clin Infect Dis. 2004 Jan 15;38(2):217-21. PubMed PMID: 14699453.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of miltefosine for childhood visceral leishmaniasis in India. AU - Bhattacharya,Sujit K, AU - Jha,T K, AU - Sundar,Shyam, AU - Thakur,C P, AU - Engel,Juergen, AU - Sindermann,Herbert, AU - Junge,Klaus, AU - Karbwang,Juntra, AU - Bryceson,Anthony D M, AU - Berman,Jonathan D, Y1 - 2003/12/18/ PY - 2003/05/30/received PY - 2003/09/01/accepted PY - 2003/12/31/pubmed PY - 2004/1/28/medline PY - 2003/12/31/entrez SP - 217 EP - 21 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 38 IS - 2 N2 - Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2-11 years) with parasitologically confirmed infection in an open-label clinical trial. Clinical and parasitological parameters were reassessed at the end of treatment and 6 months later. One patient died of intercurrent pneumonia on day 6. The other 79 patients demonstrated no parasites after treatment, had marked clinical improvement, and were deemed initially cured. Three patients had relapse, and 1 patient was lost to follow-up. The final cure rate was 94% for all enrolled patients and 95% for evaluable patients. Side effects included mild-to-moderate vomiting or diarrhea (each in approximately 25% of patients) and mild-to-moderate, transient elevations in the aspartate aminotransferase level during the early treatment phase (in 55%). This trial indicates that miltefosine is as effective and well tolerated in Indian children with VL as in adults and that it can be recommended as the first choice for treatment of childhood VL in India. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/14699453/Efficacy_and_tolerability_of_miltefosine_for_childhood_visceral_leishmaniasis_in_India_ DB - PRIME DP - Unbound Medicine ER -