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Diagnosis and Treatment of Leishmania Infections

NCT00344188 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 289

Last updated 2026-08-12

No results posted yet for this study

Summary

Patients admitted on this protocol must have an active Leishmania infection. The major objectives of the protocol are to diagnose and classify the Leishmania infection and to provide species-based therapy to study the natural history of the treated infection and further understand host and species characteristics that lead to resistant or relapsing disease. As part of the standard evaluation of these patients, biopsies to obtain parasite and host tissue will be obtained. The host response before and after therapy will be assessed to address broader questions related to diagnosis, disease pathogenesis, and response to therapy. Careful observations of the patients clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. It is anticipated that the patients will receive optimal clinical care for their infections and that the specimens collected from them will prove to be valuable reagents for the laboratory studies of the host responses unique to leishmanial infections.

Based on the nature of the disease and the recommended treatment, subjects will receive clinically appropriate treatment. Patients will undergo a limited physical examination to assess general condition, respiratory status, and skin condition. Following treatment patients are seen at 3 months and 12 months. Blood, lesion swabs, mucosal swabs, microbiopsies and/or skin biopsies will be collected for research evaluations. There will also be a mandatory check in (photos, telephone or telehealth visit) at 6 months. All of these post treatment timepoints are used to follow the course of the disease and management. Additional visits may be scheduled for clinically indicated procedures as guided by clinical status and need for evaluation. Samples collected from clinical evaluations may also be studied for research purposes and the results will be collected as part of this protocol. Participants enrolled can be assessed using an approved virtual platform. Study visits can be performed remotely if outside physicians are able to submit study specimens (blood samples, lesion and mucosal swabs).

The final study visit will typically be at 1 year following successful treatment. Blood will be collected, and swabs/microbiopsies may be collected for research evaluations at this visit. Follow up visits beyond the 1-year post-treatment point may occur on an annual basis if clinically necessary, as deemed by the investigator.

Conditions

  • Kinetoplastid
  • Skin Diseases, Parasitic
  • Parasitic Diseases
  • Leishmaniasis
  • Protozoa

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Elise M O'Connell, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
3 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00344188 on ClinicalTrials.gov