Trial record 5 of 344 for:    NIAID | Open Studies | Exclude Unknown

Diagnosis and Treatment of Leishmanial Infections

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00344188
First received: June 23, 2006
Last updated: June 11, 2014
Last verified: January 2014
  Purpose

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 For these procedures, a small tissue sample is withdrawn through a needle placed in the hipbone, liver or spleen, respectively.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.


Condition
Leishmaniasis

Study Type: Observational
Official Title: Diagnosis and Treatment of Leishmanial Infections

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 75
Study Start Date: August 2001
Detailed Description:

The major objectives of the protocol are to diagnose, treat, obtain patient isolates, determine the immune response of the host to infection, provide treatment and study the natural history of the treated infections. Another objective is to provide training for the NIH medical staff. A number of medications may be used depending on the species and geographic origin of the infecting Leishmanim potential sequelae of the infection, the health status of the patient, the ease of administration and the efficacy, morbidity and toxicities of the medication. None of the medications used to treat leishmaniasis are approved for use by the FDA. Ketoconazole, fluconazole and other azoles and AmBisome and (Amphotericin B) are readily available and have efficacy in some forms of the infection while miltefosine and Pentostam require an IND. Pentostam is available from this CDC under their IND.

  Eligibility

Ages Eligible for Study:   2 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

-

INCLUSION CRITERIA:

Individuals of either sex must be between the ages of 2 and 80 years.

Likely or proven diagnosis of leishmaniasis. Some patients have a suggestive history, were exposed at the same time as diagnosed patients and have suggestive lesions, or have a convincing history or compatible histopathology.

EXCLUSION CRITERIA:

Individuals who are pregnant or breast feeding, who do not have a life-threatening form of this disease, will be excluded from this protocol until termination of pregnancy (birth or otherwise). Those with life-threatening leishmaniasis will be offered treatment.

Those who refuse recommended treatments, evaluations, or follow up

Presence of other life threatening illness and non serious leishmaniasis

When treatment is not in the best interest of the patient s well being

Option of treatment: Not all patients with leishmaniaisis require treatment such as some patients infected with Leishmania major, a species that has few if any severe sequelae. These may be diagnosed and confirmed by culture, PCR, or histopathology at NIH and then given the option of treatment or no treatment.

Other patients have a healing lesion, which at the discretion of the physician and patient may not require treatment.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344188

Contacts
Contact: Nicole C Holland-Thomas, R.N. (301) 402-5969 hollandnc@mail.nih.gov
Contact: Theodore E Nash, M.D. (301) 496-6920 tnash@niaid.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Theodore E Nash, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00344188     History of Changes
Other Study ID Numbers: 010238, 01-I-0238
Study First Received: June 23, 2006
Last Updated: June 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cutaneous
Leishmaniasis
Visceral Mucocutaneous
Leishmanial Infection

Additional relevant MeSH terms:
Leishmaniasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014