Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344188
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2006-06-23
Brief Title:
Diagnosis and Treatment of Leishmania Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Host Response to Infection and Treatment in Leishmania Infection of Humans
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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confirmed with either a bone marrow or liver biopsy or a splenic aspirate For these procedures a small tissue sample is withdrawn through a needle placed in the hipbone liver or spleen respectively Some patients may also have a skin test for leishmaniasis similar to tuberculin skin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 collected occasionally for routine urinalysis Encapsulated amphotericin is infused every other day on an outpatient basis Blood is generally drawn every other day to every 2 days and urinalyses are done periodically Itraconazole and ketoconazole are taken orally for at least 1 to 3 months with blood drawn every 2 to 3 weeks
Patients may be asked to have photographs taken before during and after treatment to document progress They may also be asked to provide extra blood samples for research purposes either through a vein in the arm or through apheresis a method for collecting large numbers of cells For apheresis whole blood is collected through a needle in an arm vein and circulated through a machine that separates it into its components The desired cells are then removed and the rest of the blood is returned to the body either through the same needle used to draw the blood or through a second needle in the other arm
Patients with cutaneous leishmaniasis will have a follow-up clinic visit 2 weeks to 3 months after treatment is completed If there are no complications their participation will end at that time Patients with mucocutaneous leishmaniasis and visceral leishmaniasis will be followed every 3 to 6 months indefinitely for routine evaluations and re-treatment if the infection recurs
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 collected occasionally for routine urinalysis Encapsulated amphotericin is infused every other day on an outpatient basis Blood is generally drawn every other day to every 2 days and urinalyses are done periodically Itraconazole and ketoconazole are taken orally for at least 1 to 3 months with blood drawn every 2 to 3 weeks
Patients may be asked to have photographs taken before during and after treatment to document progress They may also be asked to provide extra blood samples for research purposes either through a vein in the arm or through apheresis a method for collecting large numbers of cells For apheresis whole blood is collected through a needle in an arm vein and circulated through a machine that separates it into its components The desired cells are then removed and the rest of the blood is returned to the body either through the same needle used to draw the blood or through a second needle in the other arm
Patients with cutaneous leishmaniasis will have a follow-up clinic visit 2 weeks to 3 months after treatment is completed If there are no complications their participation will end at that time Patients with mucocutaneous leishmaniasis and visceral leishmaniasis will be followed every 3 to 6 months indefinitely for routine evaluations and re-treatment if the infection recurs
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-I-0238 | None | None | None |