Post Kala Azar Dermal Leishmaniasis

Miltefosine

International Centre for Diarrheal Disease Research, Bangladesh

Miltefosine for Children With PKDL

A Study for Safety and Efficacy of Miltefosine for Treatment of Children and Adolescents With Post-Kala-azar Dermal Leishmaniasis (PKDL) in Bangladesh and Association of Serum Vitamin E and Exposure to Arsenic With PKDL

Safety will be measured by the frequency of the adverse events.

Cure will be defined by the resolution of skin lesion by ≥ 90% and skin and blood specimens negative for leishmania donovani bodies and leishmania DNA at 12 months after treatment.

This will be measured by the association by PKDL and above mentioned genetic polymorphism. Here matched children who will be found during cross sectional survey for PKDL suspects will serve as controls.

This will be measured by investigating the association of each of these nutritional factors and arsenic with the development of PKDL where matched children without PKDL will serve as control.

International Centre for Diarrhoeal Disease Research, Bangladesh

Thrasher Research Fund

Volunteers will be randomly assigned to either receive zinc sulphate supplements (20 mg/capsule) or a placebo containing no zinc. Maltodextrin serves as the carrier. Bulk boxes will identify the products as "A" and "B".

Diarrhea

Malaria

Volunteers will be randomly assigned to either receive zinc sulphate supplements (20 mg/capsule) or a placebo containing no zinc. Maltodextrin serves as the carrier. The manufacturer is Tishcon Corporation, Westbury, NY.

Zinc sulphate

Placebo

U.S. Army Research Institute of Environmental Medicine (USARIEM)

U.S. Department of Agriculture, Agricultural Research Service, Grand Forks Human Nutrition Center

Kombewa Clinical Research Center

Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.

A Randomized, Double Blind, Controlled Study to Determine the Efficacy of Zinc Supplementation on Diarrhea Incidence in an Adult Population in Western Kenya.

Diarrhea is defined as 3 or more loose motions within a period of 24 hours. Field workers will visit each subject to record diarrhea morbidity data, daily for 104 days.

Daily, field workers will visit each subject to dispense supplement and to record diarrhea morbidity data. The time between day 0 and the first bout of diarrhea will be noted.

Daily, field workers will visit each subject to dispense supplement and to record diarrhea morbidity data. With diarrhea defined as >2 loose motions within a period of 24 hours, the duration (number of days) of the diarrhea will be recorded.

Daily, field workers will visit each subject to record diarrhea morbidity data. With each bout of diarrhea, we will record the nuber of loose stools/day.

LTC Maria Bovill

United States Army Research Institute of Environmental Medicine

Walter Reed Army Institute of Research (WRAIR)

Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.

Glucantime® 20 mg /Kg /day for 20 days (intramuscular)

One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.

Glucantime®

Thermotherapy

Total

Sex: Female, Male

Region of Enrollment

Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment.
Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment.

Complete Clinical Response

Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.

Recurrence

At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment

leishmaniasis/diarrhea

Miltefosine for Children With PKDL

Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.

Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.

Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica

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