An observational study in Kinetoplastid, Skin Diseases, Parasitic and Parasitic Diseases, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in United States. Open to participants aged 3 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
Patients admitted on this protocol will have, or be suspected of having, a 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.
77 studies on the registry are indexed under Leishmaniasis; 10 are open to participants now.
This study's planned enrollment of 400 is above the median of 198 across 22 observational studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Compared within Leishmaniasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Parasitic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
This population of patients are referred from their physicians both regionally and nationally.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A: proven
OR
B: Likely diagnosis of leishmaniasis based on :
Epidemiologic exposure, clinical manifestations, and time course
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This population of patients are referred from their physicians both regionally and nationally.
Obtain a basic immune workup and biobank PBMCs, plasma, and cultured leishmania isolates
Obtain a basic immune workup and host genetic information (WGS)
Time frame: 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
Time frame: 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.
Time frame: 1 year
Determine if sequential quantitative qPCR for leishmania spp. from lesion(s) obtained by microbiopsy (nodular disease) or swabbing (ulcerative disease) correlates with healing
Examine biomarkers as predictors of clinical course
Time frame: 1 year
Assess the safety profile of varying treatment regimens
Assess the safety profile of varying treatment regimens
Time frame: 1 year
Assess the efficacy of varying treatment regimens in different species
Assess the efficacy of varying treatment regimens in different species
Time frame: 1 year
Plan to share: No — No.
Started Nov 2001 (actual).
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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