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Oral miltefosine treatment in children with mild to moderate Indian visceral leishmaniasis.
Pediatr Infect Dis J. 2003 May; 22(5):434-8.PI

Abstract

BACKGROUND

Miltefosine is the first oral drug with demonstrable success in treating visceral leishmaniasis in adults. Because approximately one-half of the visceral leishmaniasis patients worldwide are children, we performed a Phase I/II dose ranging study in the pediatric population in India.

METHODS

Thirty-nine (39) children (defined as < 12 years of age) with visceral leishmaniasis demonstrated by parasites in splenic aspirates, were treated with oral miltefosine daily for 28 days: 21 patients received 1.5 mg/kg/day (Group A); and 18 patients received 2.5 mg/kg/day (Group B). About one-half of these children had failed prior antileishmanial treatment.

RESULTS

All patients were parasitologically negative and symptomatically improved by the end of therapy on Day 28 of therapy; the initial parasitologic cure rate was 100%. Two patients in each treatment group relapsed with fever, splenomegaly and parasite-positive splenic aspirates by the end of the 6-month follow-up. The per protocol final clinical cure rate was 19 of 21 = 90% in Group A and 15 of 17 = 88% in Group B. Miltefosine was well-tolerated. As per the adult experience, gastrointestinal adverse events were seen: 33 and 39% of children experienced vomiting and 5 and 17% experienced diarrhea in Groups A and B, respectively, but all episodes were mild to moderate in severity and commonly lasted <1 day without symptomatic treatment.

CONCLUSION

Oral miltefosine was safe and approximately 90% effective in this initial clinical trial of childhood visceral leishmaniasis.

Authors+Show Affiliations

Institutes of Medical Sciences, Banaras Hindu University, 6 SK Gupta Nagar, Varanasi 221005, India. Shyams@sancharnet.inNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12792385

Citation

Sundar, Shyam, et al. "Oral Miltefosine Treatment in Children With Mild to Moderate Indian Visceral Leishmaniasis." The Pediatric Infectious Disease Journal, vol. 22, no. 5, 2003, pp. 434-8.
Sundar S, Jha TK, Sindermann H, et al. Oral miltefosine treatment in children with mild to moderate Indian visceral leishmaniasis. Pediatr Infect Dis J. 2003;22(5):434-8.
Sundar, S., Jha, T. K., Sindermann, H., Junge, K., Bachmann, P., & Berman, J. (2003). Oral miltefosine treatment in children with mild to moderate Indian visceral leishmaniasis. The Pediatric Infectious Disease Journal, 22(5), 434-8.
Sundar S, et al. Oral Miltefosine Treatment in Children With Mild to Moderate Indian Visceral Leishmaniasis. Pediatr Infect Dis J. 2003;22(5):434-8. PubMed PMID: 12792385.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral miltefosine treatment in children with mild to moderate Indian visceral leishmaniasis. AU - Sundar,Shyam, AU - Jha,T K, AU - Sindermann,Herbert, AU - Junge,Klaus, AU - Bachmann,Peter, AU - Berman,Jonathan, PY - 2003/6/7/pubmed PY - 2003/7/30/medline PY - 2003/6/7/entrez SP - 434 EP - 8 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 22 IS - 5 N2 - BACKGROUND: Miltefosine is the first oral drug with demonstrable success in treating visceral leishmaniasis in adults. Because approximately one-half of the visceral leishmaniasis patients worldwide are children, we performed a Phase I/II dose ranging study in the pediatric population in India. METHODS: Thirty-nine (39) children (defined as < 12 years of age) with visceral leishmaniasis demonstrated by parasites in splenic aspirates, were treated with oral miltefosine daily for 28 days: 21 patients received 1.5 mg/kg/day (Group A); and 18 patients received 2.5 mg/kg/day (Group B). About one-half of these children had failed prior antileishmanial treatment. RESULTS: All patients were parasitologically negative and symptomatically improved by the end of therapy on Day 28 of therapy; the initial parasitologic cure rate was 100%. Two patients in each treatment group relapsed with fever, splenomegaly and parasite-positive splenic aspirates by the end of the 6-month follow-up. The per protocol final clinical cure rate was 19 of 21 = 90% in Group A and 15 of 17 = 88% in Group B. Miltefosine was well-tolerated. As per the adult experience, gastrointestinal adverse events were seen: 33 and 39% of children experienced vomiting and 5 and 17% experienced diarrhea in Groups A and B, respectively, but all episodes were mild to moderate in severity and commonly lasted <1 day without symptomatic treatment. CONCLUSION: Oral miltefosine was safe and approximately 90% effective in this initial clinical trial of childhood visceral leishmaniasis. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/12792385/Oral_miltefosine_treatment_in_children_with_mild_to_moderate_Indian_visceral_leishmaniasis_ L2 - https://doi.org/10.1097/01.inf.0000066877.72624.cb DB - PRIME DP - Unbound Medicine ER -