Official Title: “Diagnosis and Treatment of Leishmanial Infections”

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 For these procedures, a small tissue sample is withdrawn through a needle placed in the hipbone, liver or spleen, respectively.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.

Study Type: Observational

Study Design: N/A

Study Primary Completion Date: July 2011

The major objectives of the protocol are to diagnose, treat, determine the immune responses of the host to infection and the study natural history of infection. Another objective is to provide training for the NIH medical staff. A number of medications may be used depending on the species and geographic origin of the infecting Leishmanim potential sequelae of the infection, the health status of the patient, and the ease of administration. None of the medications used to treat leishmaniasis are approved for use by the FDA. Ketoconazole, fluconazole and other azoles and Ambisome (amphotericin) are readily available and have efficacy in some forms of the infection while miltefosine and Pentostam require an IND.

INCLUSION CRITERIA:

• Individuals of either sex must be between the ages of 2 and 80 years.
• Individuals must have a parasitologic diagnosis confirmed by culture or PCR at the NIH. In some instances, a diagnosis established at some other facility, or based upon clinical and convincing histopathological evidence may allow inclusion.

EXCLUSION CRITERIA:

• Individuals who are pregnant or breast feeding, who do not have a life-threatening form of this disease, will be excluded from this protocol until termination of pregnancy (birth or otherwise). Those with life-threatening leishmaniasis will be offered treatment.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Overall Clinical Trial Officials and Contacts

Overall Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00344188

Study ID Number: 010238

ClinicalTrials.gov Identifier: NCT00344188

Health Authority: United States: Federal Government

NIH Clinical Center Detailed Web Page