Efficacy and Tolerability of Miltefosine for Childhood Visceral Leishmaniasis in India

Bhattacharya, Sujit K.; Jha, T. K.; Sundar, Shyam; Thakur, C. P.; Engel, Juergen; Sindermann, Herbert; Junge, Klaus; Karbwang, Juntra; Bryceson, Anthony D. M.; Berman, Jonathan D.
January 2004
Clinical Infectious Diseases;1/15/2004, Vol. 38 Issue 2, p217
Academic Journal
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 ∼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.


Related Articles

  • Clinical Trial Design and Consequences for Drug Development for Community-Acquired Pneumonia: An Industry Perspective. Tillotson, Glenn S.; Echols, Roger M. // Clinical Infectious Diseases;12/1/2008 Supplement 3, Vol. 47, pS237 

    Antibiotic development has decreased significantly, in part because of recent changes in regulatory requirements in the United States. These changes both decrease the probability of technical and regulatory success for a new antibiotic for which marketing approval is sought and motivate the...

  • POINT/COUNTER.  // Ocular Surgery News;2/25/2009, Vol. 27 Issue 4, p11 

    The article presents opposing views on ongoing CATT studies regarding the treatment for wet age-related macular degeneration (AMD). Physician Sophie J. Bakri expects the trial results to tell if Avastin is non-inferior to Lucentis when given on a monthly basis, and if each drug is better given...

  • Combo lowered cholesterol, improved triglycerides.  // Cardiology Today;Feb2008, Vol. 11 Issue 2, p20 

    The article reports on the result of the phase-3 clinical trial titled SEACOAST in the U.S. The 24-week clinical trial compared simvastatin alone with a combination of drugs niacin and simvastatin in 600 patients with non-HDL. Moreover, result shows that 6% of the patients on the combination of...

  • Review backs memantine.  // Pulse;4/20/2006, Vol. 66 Issue 16, p6 

    The article discusses a research by Rupert McShane and colleagues, which showed the clinical efficacy of memantine in the treatment of moderate to severe Alzheimer's disease. It suggests that memantine should only be used as part of a clinical study. Memantine might also help prevent agitation...

  • Critical Assessment of Belgian Reimbursement Dossiers of Orphan Drugs. Denis, Alain; Mergaert, Lut; Fostier, Christel; Cleemput, Irina; Hulstaert, Frank; Simoens, Steven // PharmacoEconomics;2011, Vol. 29 Issue 10, p883 

    Background: Orphan medicinal products are designed to diagnose or treat rare diseases that are serious, life threatening or chronically debilitating and that affect 50 or fewer people in every 100 000 in the EU. In Belgium, the Drug Reimbursement Committee (DRC) evaluates reimbursement requests...

  • Winning the Cold War. Jolda, Deb // Applied Clinical Trials;Jul2000, Vol. 9 Issue 7, p48 

    Interviews a participant involved in the clinical trials of a drug for the treatment of the common cold. Payment received for participating in the trial; Knowledge on the clinical trial processes; Absence of side effects of the drug; Professionalism displayed by the staff conducting the trials.

  • How to Find a Trial. Smith, Ian K. // Time International (South Pacific Edition);11/22/99, Issue 47, p76 

    Offers information on patient enrollment in clinical drug trials. Researchers' need for patients as well as patients' need for treatment; Reasons adults do not participate in clinical drug trials; Where to locate trials. INSETS: Ace-ing It;Inside Information;Minitel Mini-Stroke;Couch Potatoes...

  • Malaria: Joint attack on malaria. Ellis, Clare // Nature Reviews Microbiology;Sep2004, Vol. 2 Issue 9, p689 

    The article reports on the success of the study conducted by a group of international scientists that to develop a new antimalarial drug. The team, that is consists of researchers from universities and medical-related institutions worldwide, aims to identify a new synthetic peroxide antimalarial...

  • Enteric-Coated Charcoal as a Means of Blinding Studies Comparing Bismuth and H2-Receptor Antagonists. Yates, Scott; Barnett, Cora; Peterson, Walter L. // American Journal of Gastroenterology;Aug1992, Vol. 87 Issue 8, p981 

    Clinical trials comparing H2-receptor antagonists and bismuth-containing regimens in ulcer healing, ulcer relapse, or dyspepsia have not been double-blind, because bismuth darkens stools. This study was designed to determine whether enteric-coated charcoal could darken stools of subjects taking...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics