Diagnosis and Treatment of Leishmania Infections
Public ClinicalTrials.gov record NCT00344188. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Host Response to Infection and Treatment in Leishmania Infection of Humans
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00344188
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 289 participants
Conditions and interventions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 3 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 29, 2001
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Aug 30, 2026
Started 2001
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00344188, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00344188 live on ClinicalTrials.gov.