Understanding and treating Leishmania infections
Host Response to Infection and Treatment in Leishmania Infection of Humans
National Institutes of Health Clinical Center (CC) · NCT00344188
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 |
|---|---|
| Enrollment | 289 (estimated) |
| Ages | 3 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00344188 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 2 to 80 years with a confirmed or suspected diagnosis of leishmaniasis.
Not a fit: Patients with conditions that may pose undue risk or make them unsuitable for participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance diagnostic accuracy and treatment options for patients with leishmaniasis.
How similar studies have performed: Other studies have shown success in understanding leishmaniasis, but this specific approach to studying the natural history and host responses is relatively novel.
Eligibility criteria
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. 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Leishmaniasis, Skin Diseases, Parasitic, Euglenozoa Infections, Parasitic Diseases, Cutaneous, Visceral, Leishmanial Infection, MucocutaneousLeishmaniasis