Diagnosis and Treatment of Leishmania Infections

NCT00344188 | Recruiting

• 2 other identifiers: 01023801-I-0238
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

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 For these procedures, a small tissue sample is withdrawn through a needle placed in the hipbone, liver or spleen, respectively.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

Conditions

Leishmaniasis; Skin Diseases, Parasitic; Euglenozoa Infections; Parasitic Diseases

Keywords

Cutaneous; Visceral; Leishmanial Infection; MucocutaneousLeishmaniasis; Natural History

Outcome Measures

Primary Outcomes (3)

• Obtain phenotypic and clinical information to document refractory and relapsing clinical courses.

  Obtain phenotypic and clinical information to document refractory and relapsing clinical courses.

  1 year

• Obtain organism genomic data at the initial time of NIH presentation and any further relapses

  Obtain organism genomic data at the initial time of NIH presentation and any further relapses

  1 year

• Obtain a basic immune workup and host genetic information (WGS)

  Obtain a basic immune workup and host genetic information (WGS)

  1 year

Secondary Outcomes (2)

• Assess the efficacy of varying treatment regimens in different species

  1 year

• Assess the safety profile of varying treatment regimens

  1 year

Study Arms (1)

1

This population of patients are referred from their physicians both regionally and nationally.

Eligibility Criteria

• Age: 3 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This population of patients are referred from their physicians both regionally and nationally.

You may qualify if:

• Individuals aged 3 to 100 years.
• Diagnosis of leishmaniasis:
• A: Biopsy proven
• B: Likely diagnosis of leishmaniasis based on :
• Epidemiologic exposure, clinical manifestations, and time course
• Willingness to allow samples to be stored for future research.

You may not qualify if:

• Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Leishmaniasis; Skin Diseases, Parasitic; Euglenozoa Infections; Parasitic Diseases

Condition Hierarchy (Ancestors)

Protozoan Infections; Infections; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elise M O'Connell, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise M O'Connell, M.D.

CONTACT

(301) 761-5413; oconnellem@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 26, 2006
• Study Start: November 30, 2001
• Last Updated: May 1, 2026

Record last verified: 2026-03-13

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)