Diagnosis and Treatment of Leishmanial Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00344188
Recruitment Status : Recruiting
First Posted : June 26, 2006
Last Update Posted : December 6, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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 For these procedures, a small tissue sample is withdrawn through a needle placed in the hipbone, liver or spleen, respectively.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

Condition or disease

Detailed Description:
The major objectives of the protocol are to diagnose, obtain patient isolates, determine the immune responses of the host to infection, provide treatment and study the natural history of the treated infections. Another objective is to provide training for the NIH medical staff. Most cutaneous lesions caused by Leishmania tend to self-heal so no treatment may be the most prudent course. Both local treatments and systemic drugs can be effective depending on the species, geographic origin of the Leishmania, and the number and location of the lesions. The goal of treatment is to hasten healing, prevent damage/scarring on the face, sexual organs or other critical regions and cutaneous superinfection, and possibly lessen the chance of spread to the mucosa of the upper respiratory tract and mouth. Visceral leishmaniasis is rarely seen in the U.S. and always requires treatment when clinically evident. A number of systemic medications may be used but their effectiveness also depends on the species and geographic origin of the infecting Leishmania, potential sequelae of the infection, the health status of the patient, the ease of administration and the efficacy, morbidity and toxicities of the medication. Miltefosine (Impavido) and Ambisome are the only drugs approved by the CDC to treat cutaneous and visceral leishmaniasis, respectively. Ketoconazole, fluconazole and other azoles as well as other treatments are readily available and have efficacy in some forms of the infection.

Study Type : Observational
Estimated Enrollment : 200 participants
Official Title: Diagnosis and Treatment of Leishmanial Infections
Study Start Date : August 22, 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Individuals of either sex must be between the ages of 2 and 80 years.

Likely or proven diagnosis of leishmaniasis. Some patients have a suggestive history, were exposed at the same time as diagnosed patients and have suggestive lesions, or have a convincing history or compatible histopathology.

Weigh at least 66 lbs if treated with miltefosine.

Agree to use 2 methods of birth control (pills or barrier method and abstinence) and delay pregnancy/fatherhood during treatment and for 6 months after the treatment ends if treated with miltefosine.

Negative pregnancy tests within 24 hours of initiating drug for all systemic treatments.


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.

Those who refuse recommended treatments, evaluations, or follow up

Presence of other life threatening-illness and non serious leishmaniasis

When treatment is not in the best interest of the patient s well being

Option of treatment: Not all patients with leishmaniaisis require treatment such as some patients infected with Leishmania major, a species that has few if any severe sequelae. These may be diagnosed and confirmed by culture, PCR, or histopathology at NIH and then given the option of treatment or no treatment.

Other patients have a healing lesion, which at the discretion of the physician and patient may not require treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00344188

Contact: Nicole C Holland-Thomas, R.N. (301) 402-5969
Contact: Theodore E Nash, M.D. (301) 496-6920

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Theodore E Nash, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00344188     History of Changes
Other Study ID Numbers: 010238
First Posted: June 26, 2006    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: November 2, 2018

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Leishmanial Infection

Additional relevant MeSH terms:
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases