Track topics on Twitter Track topics that are important to you
The purpose of this Treatment IND is to make miltefosine available for mucocutaneous leishmaniasis patients presenting in the United States.
If entrance criteria are met, subjects with mucosal or cutaneous leishmaniasis will receive miltefosine at a targeted dose of 2.5 mg/kg/day for 28 days. During treatment at weeks 1, 2, and 4, the patient will return to the treatment facility to be assessed for adverse events. Blood for transaminase and creatinine values will be drawn at the midpoint and at the end of therapy.
Patients will return to the treatment facility to be examined clinically at 6 wks (ie, 2 wks after the end of therapy), 3 months (2 months after therapy), and 7 months (6 months after treatment) for ML and CL patients, and also at 13 months (12 months after treatment) for ML patients.
Control: Historical Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
for this treatment IND, each Physician will enter patients at his/her own facility. Below data is for Protocol central contact
Paladin Labs (USA) Inc.
Published on BioPortfolio: 2014-08-27T03:16:34-0400
Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis
Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliens...
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse...
The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous st...
The purpose of this study is to determine the pharmacokinetics of miltefosine in children and adults with cutaneous leishmaniasis in plasma and intracellularly, and its relation with the p...
Low efficacy of miltefosine in the treatment of visceral leishmaniasis was recently observed in Eastern Africa.
The potential reservoirs of Leishmaniasis in South Asia include relapsed cases of visceral leishmaniasis, patients with Post-Kala-azar dermal leishmaniasis (PKDL) and an asymptomatically infected popu...
American Tegumentary Leishmaniasis (ATL) caused by Leishmania braziliensis is endemic in Corte de Pedra, Northeast Brazil. Most L. braziliensis infections manifest as localized cutaneous leishmaniasis...
Tegumentary leishmaniasis (TL) is a disease of skin and/or mucosal tissues caused by Leishmania parasites. TL patients may concurrently carry other pathogens, which may influence the clinical outcome ...
Reevaluation of treatment guidelines for Old and New World leishmaniasis is urgently needed on a global basis because treatment failure is an increasing problem. Drug resistance is a fundamental deter...
A disease caused by any of a number of species of protozoa in the genus LEISHMANIA. There are four major clinical types of this infection: cutaneous (Old and New World) (LEISHMANIASIS, CUTANEOUS), diffuse cutaneous (LEISHMANIASIS, DIFFUSE CUTANEOUS), mucocutaneous (LEISHMANIASIS, MUCOCUTANEOUS), and visceral (LEISHMANIASIS, VISCERAL).
A parasitic hemoflagellate of the subgenus Leishmania leishmania that infects man and animals including rodents. The Leishmania mexicana complex causes both cutaneous (LEISHMANIASIS, CUTANEOUS) and diffuse cutaneous leishmaniasis (LEISHMANIASIS, DIFFUSE CUTANEOUS) and includes the subspecies amazonensis, garnhami, mexicana, pifanoi, and venezuelensis. L. m. mexicana causes chiclero ulcer, a form of cutaneous leishmaniasis (LEISHMANIASIS, CUTANEOUS) in the New World. The sandfly, Lutzomyia, appears to be the vector.
A parasitic hemoflagellate of the subgenus Leishmania viannia that infects man and animals. It causes cutaneous (LEISHMANIASIS, CUTANEOUS), diffuse cutaneous (LEISHMANIASIS, DIFFUSE CUTANEOUS), and mucocutaneous leishmaniasis (LEISHMANIASIS, MUCOCUTANEOUS) depending on the subspecies of this organism. The sandfly, Lutzomyia, is the vector. The Leishmania braziliensis complex includes the subspecies braziliensis and peruviana. Uta, a form of cutaneous leishmaniasis in the New World, is caused by the subspecies peruviana.
An endemic disease that is characterized by the development of single or multiple localized lesions on exposed areas of skin that typically ulcerate. The disease has been divided into Old and New World forms. Old World leishmaniasis is separated into three distinct types according to epidemiology and clinical manifestations and is caused by species of the L. tropica and L. aethiopica complexes as well as by species of the L. major genus. New World leishmaniasis, also called American leishmaniasis, occurs in South and Central America and is caused by species of the L. mexicana or L. braziliensis complexes.
A parasitic hemoflagellate of the subgenus Leishmania viannia that infects man and animals and causes mucocutaneous leishmaniasis (LEISHMANIASIS, MUCOCUTANEOUS). Transmission is by Lutzomyia sandflies.