KinetoplastidNCT00344188
Diagnosis and Treatment of Leishmania Infections
An observational study of Kinetoplastid and Skin Diseases, Parasitic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 100 years
- Conditions the study is for
- Kinetoplastid, Skin Diseases, Parasitic, Parasitic Diseases
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2001to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This population of patients are referred from their physicians both regionally and nationally.
Who may be able to join
- 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.
- Ability to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Lori Penrod, 240-627-3647, lpenrod@niaid.nih.gov
About this study
Official title: Host Response to Infection and Treatment in Leishmania Infection of Humans
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.
Read the detailed description
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.
- Keywords
- mucosal leishmaniasis, Visceral leishmaniasis, Natural History, Mucocutaneous Leishmaniasis, Leishmania, CUTANEOUS LEISHMANIASIS
- Medical subject headings
- Skin Diseases, Parasitic, Parasitic Diseases, Leishmaniasis, Leishmaniasis, Mucocutaneous, Leishmaniasis, Visceral, Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | This population of patients are referred from their physicians both regionally and nationally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain a basic immune workup and biobank PBMCs, plasma, and cultured leishmania isolates
Obtain a basic immune workup and host genetic information (WGS)
Measured: 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
Measured: 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.
Measured: 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
Examine biomarkers as predictors of clinical course
Measured: 1 year
Assess the safety profile of varying treatment regimens
Assess the safety profile of varying treatment regimens
Measured: 1 year
Assess the efficacy of varying treatment regimens in different species
Assess the efficacy of varying treatment regimens in different species
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study start30 Nov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinetoplastidStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elise M O'Connell, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344188
- Sponsor's protocol ID
- 010238
- Other IDs
- 01-I-0238
- Status last verified
- 28 Sep 2026
- First submitted
- 23 Jun 2006
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Response to Infection and Treatment in Leishmania Infection of Humans
- ClinicalTrials.gov ID
- NCT00344188
- Acronym / sponsor ID
- 010238
- Keywords
- mucosal leishmaniasis, Visceral leishmaniasis, Natural History, Mucocutaneous Leishmaniasis, Leishmania, CUTANEOUS LEISHMANIASIS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 30 Nov 2001 (actual)
- First posted
- 26 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –This population of patients are referred from their physicians both regionally and nationally. |
Who may qualify
- Ages
- 3 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This population of patients are referred from their physicians both regionally and nationally.
Key inclusion criteria (8 listed)
- Individuals aged 3 to 100 years.
- Diagnosis of leishmaniasis:
- A: Biopsy proven
- OR
- Epidemiologic exposure, clinical manifestations, and time course
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obtain a basic immune workup and biobank PBMCs, plasma, and cultured leishmania isolates
Time frame: 1 year
Obtain a basic immune workup and host genetic information (WGS)
Obtain organism genomic data at the initial time of NIH presentation and any further relapses
Time frame: 1 year
Obtain organism genomic data at the initial time of NIH presentation and any further relapses
Obtain phenotypic and clinical information to document refractory and relapsing clinical courses.
Time frame: 1 year
Obtain phenotypic and clinical information to document refractory and relapsing clinical courses.
3 secondary outcomes
Determine if sequential quantitative qPCR for leishmania spp. from lesion(s) obtained by microbiopsy (nodular disease) or swabbing (ulcerative disease) correlates with healing
Time frame: 1 year
Assess the safety profile of varying treatment regimens
Time frame: 1 year
Assess the efficacy of varying treatment regimens in different species
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. No.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elise M O'Connell, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kinetoplastid and Skin Diseases, Parasitic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise M O'Connell, M.D. ((301) 761-5413, oconnellem@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain a basic immune workup and biobank PBMCs, plasma, and cultured leishmania isolates (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.