Understanding and treating Leishmania infections
Official title: Host Response to Infection and Treatment in Leishmania Infection of Humans
Run by National Institutes of Health Clinical Center (CC) · NCT00344188 · Data updated 2026-11-12
This study is trying to better understand Leishmania infections and find the best treatments for people aged 2 to 80 who have or might have this disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 100 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | November 30, 2001 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT00344188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 2 to 80 years with a confirmed or suspected diagnosis of leishmaniasis.
✕Probably not a fit
Patients with conditions that may pose undue risk or make them unsuitable for participation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the natural history of Leishmanial infections and their treatments. It aims to improve diagnostic tests and provide species-based therapy for patients with known or suspected leishmaniasis. Participants, aged 2 to 80, will undergo routine blood tests and biopsies to confirm the type of infection, which may include cutaneous, mucocutaneous, or visceral leishmaniasis. The study will assess the host response to therapy and collect valuable specimens for further research on disease pathogenesis and treatment responses.
Why it matters
Potential benefit: If successful, this study could enhance diagnostic accuracy and treatment options for patients with leishmaniasis.
How similar studies have gone: Other studies have shown success in understanding leishmaniasis, but this specific approach to studying the natural history and host responses is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Individuals aged 3 to 100 years. * Diagnosis of leishmaniasis: A: Biopsy proven OR B: Likely diagnosis of leishmaniasis based on : Epidemiologic exposure, clinical manifestations, and time course * Willingness to allow samples to be stored for future research. * Ability to provide informed consent. EXCLUSION CRITERIA: 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.
Where it's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Elise M O'Connell, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Elise M O'Connell, M.D.
- Email: oconnellem@mail.nih.gov
- Phone: (301) 761-5413
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Immunogenicity screening of Leishmania vaccine candidate antigens in Ethiopian patients
This study tests whether six Leishmania vaccine candidate antigens can trigger T-cell responses in patients with cutaneous or visceral leishmaniasis.
-
Community spread of multiple infectious diseases in Cambodia from a One Health perspective
This project will test how common and connected dengue, chikungunya, Zika, Japanese encephalitis, and West Nile infections are among people, animals, and the environment across Cambodia.
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Identifying biomarkers for Leishmaniasis infections
This study is trying to find specific markers in blood samples that can help identify Leishmaniasis infections in people, including those who are infected and those who are not.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.