Actively Recruiting
Host Response to Infection and Treatment in Leishmania Infection of Humans
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-01
289
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the natural history and treatment of leishmanial infections in patients aged 3 to 100 years. The study aims to better understand leishmaniasis, improve diagnostic tests, and observe how different species and host factors affect disease resistance and relapse. The National Institute of Allergy and Infectious Diseases (NIAID) is leading this observational research. Patients suspected or known to have leishmaniasis will undergo routine blood tests and biopsies tailored to the infection type: cutaneous, mucocutaneous, or visceral. Treatment varies by infection type and may include medications like Pentostam, amphotericin B, itraconazole, or ketoconazole with different dosing schedules and administration methods such as infusions or oral pills. Some patients may have skin tests similar to tuberculin testing, and treatments involve monitoring through blood draws, electrocardiograms, and urinalysis. Participants may have photographs taken and provide extra blood samples for research. Follow-up visits depend on the infection type, ranging from short-term (2 weeks to 3 months) for cutaneous cases to indefinite routine evaluations every 3 to 6 months for mucocutaneous and visceral infections. Researchers will assess clinical and immune responses, treatment safety and effectiveness, and collect genetic and immune data over time to understand infection outcomes.
CONDITIONS
Brief Title
Diagnosis and Treatment of Leishmania Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 3 to 100 years.
- Diagnosis of leishmaniasis confirmed by biopsy.
- Or likely diagnosis based on exposure, symptoms, and disease course.
- Willingness to allow samples to be stored for future research.
You will not qualify if you...
- Any condition that may put the participant at undue risk or make them unsuitable for the study, as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Initial evaluation period
Participants undergo biopsies and clinical assessments to diagnose and classify Leishmania infection and to obtain parasite and host tissue samples.
1 to 2 visits depending on clinical presentation
Duration - Up to 1 year
Participants are observed to study the natural history of treated infection, host response, and clinical outcomes including refractory and relapsing disease over time.
Ongoing assessments during follow-up visits
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
E
Elise M O'Connell, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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