NCT00344188

Diagnosis and Treatment of Leishmania Infections

Recruiting now Last updated 14 April 2026

What this trial tests

trial in Leishmaniasis in 289 participants. Currently enrolling.

Timeline

30 November 2001

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	289
Start date	30 November 2001
Sites	1 location across United States

Conditions studied

• Leishmaniasis — all drugs for Leishmaniasis →
• Skin Diseases, Parasitic — all drugs for Skin Diseases, Parasitic →
• Euglenozoa Infections — all drugs for Euglenozoa Infections →
• Parasitic Diseases — all drugs for Parasitic Diseases →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 3 to 100, any sex, with Leishmaniasis or Skin Diseases, Parasitic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 For these procedures, a small tissue sample is withdrawn through a needle placed in the hipbone, liver or spleen, respectively.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

...

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and Tolerability of Miltefosine in the Treatment of Cutaneous Leishmaniasis.
   Ware JM, O'Connell EM, Brown T, Wetzler L, et al · · 2021 · cited 34× · PMID 33124666 · DOI 10.1093/cid/ciaa1238
2. Exploring EGCG for Leishmaniasis: A Natural Strategy for Neglected Disease Intervention.
   Ahmed KA, Ahmad U, Akhtar J, Islam A, et al · · 2025 · PMID 41477459 · DOI 10.59249/gowl3285
3. From Skin to Sequence: Pan-species Detection and Speciation of Leishmania.
   Duncan NR, O'Connell EM, Guzmán JJ, Lacsina JR, et al · · 2026 · PMID 40570150 · DOI 10.1093/infdis/jiaf345