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NCT00344188 · ClinicalTrials.gov registry record
Diagnosis and Treatment of Leishmania Infections
A clinical trial of Leishmaniasis and Skin Diseases, Parasitic, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 289
- Enrollment target
- 1
- Study location
NCT00344188: Recruiting study of Leishmaniasis and Skin Diseases, Parasitic, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00344188 is a study of Leishmaniasis and Skin Diseases, Parasitic that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 289 participants, above the 195-participant average among 3 other Leishmaniasis trials with a reported enrollment target (48% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00344188, a study of Leishmaniasis and Skin Diseases, Parasitic, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 289 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the natural history of Leishmanial infections and their treatments. It will provide an opportunity for NIAID staff to learn more about leishmaniasis and perhaps to improve diagnostic tests for these infections. Patients between 2 and 80 years of age with known or suspected leishmaniasis are eligible for this study. Participants will have routine blood tests and a biopsy to confirm leishmanial infection. The biopsy procedure will be determined by the type of infection local cutaneous leishmaniasis (LCL), mucocutaneous leishmaniasis (MCL) or visceral leishmaniasis (VL). CL will be confirmed with a punch biopsy, in which a cookie-cutter type razor is used to remove a small circular piece of skin tissue. MCL will be confirmed using a thin flexible tube inserted into the nose. This tube is used to examine the nose and upper airway and to remove a tissue sample, if an affected area is seen. VL will be confirmed with either a bone marrow or liver biopsy or a splenic aspirate. For these procedures, a small tissue sample is withdrawn through a needle placed in the hipbone, liver or spleen, respectively. Some patients may also have a skin test for leishmaniasis similar to tuberculin skin testing. Treatment and length of hospital stay are determined by the type of infection. CL may be treated with Pentostam, amphotericin, amphotericin B, itraconazole or ketoconazole; ML with amphotericin B, or encapsulated amphotericin; and VL with Pentostam or encapsulated amphotericin. Pentostam is infused daily for 18 to 28 doses, most as an outpatient. Blood is drawn 3 times a week for safety tests and an electrocardiogram is done 2 to 3 times a week to monitor heart rhythm. Amphotericin B is infused every day or every other day for about 30 doses, all on an inpatient basis. Patients undergo hydration (infusion of a large amount of fluid) just before and immediately after each infusion to protect the kidneys. Blood is drawn every other day and urine samples are co
Primary Outcome
Obtain a basic immune workup and host genetic information (WGS)
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2001-11-30 |
What NCT00344188 shows while recruiting
NCT00344188 is an observational study that tracks outcomes without assigning an intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, above the 195-participant average among 3 other Leishmaniasis trials with a reported enrollment target (48% higher).
The record links to 4 conditions, with Leishmaniasis appearing as the primary indexed condition, and to 0 interventions.
NCT00344188 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00344188 about?
NCT00344188 is a clinical study titled "Diagnosis and Treatment of Leishmania Infections". This study will examine the natural history of Leishmanial infections and their treatments. It will provide an opportunity for NIAID staff to learn more about leishmaniasis and perhaps to improve diagnostic tests for these infections. Patients between 2 and 80 years of age with known or suspected le...
What is the current status of trial NCT00344188?
This trial is currently recruiting. The enrollment target is 289 participants. The study started on 2001-11-30.
What conditions does trial NCT00344188 study?
This clinical trial studies the following conditions: Leishmaniasis, Skin Diseases, Parasitic, Euglenozoa Infections, Parasitic Diseases.
Who is sponsoring clinical trial NCT00344188?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00344188 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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