Clinical Trial Summary
This study will examine the natural history of Leishmanial infections and their treatments.
It will provide an opportunity for NIAID staff to learn more about leishmaniasis and perhaps
to improve diagnostic tests for these infections. Patients between 2 and 80 years of age with
known or suspected leishmaniasis are eligible for this study.
Participants will have routine blood tests and a biopsy to confirm leishmanial infection. The
biopsy procedure will be determined by the type of infection local cutaneous leishmaniasis
(LCL), mucocutaneous leishmaniasis (MCL) or visceral leishmaniasis (VL). CL will be confirmed
with a punch biopsy, in which a cookie-cutter type razor is used to remove a small circular
piece of skin tissue. MCL will be confirmed using a thin flexible tube inserted into the
nose. This tube is used to examine the nose and upper airway and to remove a tissue sample,
if an affected area is seen. VL will be confirmed with either a bone marrow or liver biopsy
or a splenic aspirate. For these procedures, a small tissue sample is withdrawn through a
needle placed in the hipbone, liver or spleen, respectively. Some patients may also have a
skin test for leishmaniasis similar to tuberculin skin testing.
Treatment and length of hospital stay are determined by the type of infection. CL may be
treated with Pentostam, amphotericin, amphotericin B, itraconazole or ketoconazole; ML with
amphotericin B, or encapsulated amphotericin; and VL with Pentostam or encapsulated
amphotericin. Pentostam is infused daily for 18 to 28 doses, most as an outpatient. Blood is
drawn 3 times a week for safety tests and an electrocardiogram is done 2 to 3 times a week to
monitor heart rhythm. Amphotericin B is infused every day or every other day for about 30
doses, all on an inpatient basis. Patients undergo hydration (infusion of a large amount of
fluid) just before and immediately after each infusion to protect the kidneys. Blood is drawn
every other day and urine samples are collected occasionally for routine urinalysis.
Encapsulated amphotericin is infused every other day, on an outpatient basis. Blood is
generally drawn every other day to every 2 days and urinalyses are done periodically.
Itraconazole and ketoconazole are taken orally for at least 1 to 3 months, with blood drawn
every 2 to 3 weeks.
Patients may be asked to have photographs taken before, during and after treatment to
document progress. They may also be asked to provide extra blood samples for research
purposes, either through a vein in the arm or through apheresis, a method for collecting
large numbers of cells. For apheresis, whole blood is collected through a needle in an arm
vein and circulated through a machine that separates it into its components. The desired
cells are then removed, and the rest of the blood is returned to the body, either through the
same needle used to draw the blood or through a second needle in the other arm.
Patients with cutaneous leishmaniasis will have a follow-up clinic visit 2 weeks to 3 months
after treatment is completed. If there are no complications, their participation will end at
that time. Patients with mucocutaneous leishmaniasis and visceral leishmaniasis will be
followed every 3 to 6 months indefinitely for routine evaluations and re-treatment if the
infection recurs.
Patients admitted on this protocol will have, or be suspected of having, a Leishmania
infection. The major objectives of the protocol are to diagnose and classify the Leishmania
infection and to provide species-based therapy to study the natural history of the treated
infection and further understand host and species characteristics that lead to resistant or
relapsing disease. As part of the standard evaluation of these patients, biopsies to obtain
parasite and host tissue will be obtained. The host response before and after therapy will be
assessed to address broader questions related to diagnosis, disease pathogenesis, and
response to therapy. Careful observations of the patients clinical and immunologic responses
to therapy will be made, as well as long-term follow-up of these changes. It is anticipated
that the patients will receive optimal clinical care for their infections and that the
specimens collected from them will prove to be valuable reagents for the laboratory studies
of the host responses unique to leishmanial infections.
