Diagnosis and Treatment of Leishmania Infections

NCT00344188 | Recruiting

• 2 other identifiers: 01023801-I-0238
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Leishmaniasis; Skin Diseases, Parasitic; Protozoa; Kinetoplastid; Parasitic Diseases

Keywords

mucosal leishmaniasis; Visceral leishmaniasis; Natural History; Mucocutaneous Leishmaniasis; Leishmania; CUTANEOUS LEISHMANIASIS

Outcome Measures

Primary Outcomes (3)

• Obtain a basic immune workup and biobank PBMCs, plasma, and cultured leishmania isolates

  Obtain a basic immune workup and host genetic information (WGS)

  1 year

• Obtain organism genomic data at the initial time of NIH presentation and any further relapses

  Obtain organism genomic data at the initial time of NIH presentation and any further relapses

  1 year

• Obtain phenotypic and clinical information to document refractory and relapsing clinical courses.

  Obtain phenotypic and clinical information to document refractory and relapsing clinical courses.

  1 year

Secondary Outcomes (3)

• Determine if sequential quantitative qPCR for leishmania spp. from lesion(s) obtained by microbiopsy (nodular disease) or swabbing (ulcerative disease) correlates with healing

  1 year

• Assess the safety profile of varying treatment regimens

  1 year

• Assess the efficacy of varying treatment regimens in different species

  1 year

Study Arms (1)

1

This population of patients are referred from their physicians both regionally and nationally.

Eligibility Criteria

• Age: 3 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This population of patients are referred from their physicians both regionally and nationally.

You may qualify if:

• Individuals aged 3 to 100 years.
• Diagnosis of leishmaniasis:
• A: Biopsy proven
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Skin Diseases, Parasitic; Parasitic Diseases; Leishmaniasis; Leishmaniasis, Mucocutaneous; Leishmaniasis, Visceral; Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Euglenozoa Infections; Protozoan Infections; Vector Borne Diseases

Study Officials

• Elise M O'Connell, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise M O'Connell, M.D.

CONTACT

(301) 761-5413; oconnellem@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 26, 2006
• Study Start: November 30, 2001
• Last Updated: October 2, 2026

Record last verified: 2026-09-28

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)