Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01380301
Recruitment Status : Terminated (Low efficacy rates)
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
AB Foundation
Information provided by:
Foundation Fader

Brief Summary:

Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93% and the cure rate in Bolivia is also 90%. Nevertheless, pentavalent antimonials have the disadvantages of multiple injections and mild-moderate clinical toxicity all of which are particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.

The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and Bolivia (91 and 92% respectively). Side effects seen in patients with cutaneous disease that can be specifically attributed to the drug are nausea and vomiting of mild grade in approximately 25% of patients, and low-grade elevation of creatinine also in approximately 25% of patients. A further disadvantage of miltefosine is that regimens shorter than 4 weeks have not been evaluated for cutaneous disease.

Combination therapy is now being used for many infectious diseases, such as tuberculosis, malaria, and HIV. Combination therapy offers the potential of preventing drug resistance, because organisms resistant to one of the drugs may be susceptible to the other drug; and also the potential to diminish drug therapy duration and thus side effects. These two potential benefits to some extent contradict each other: preventing resistance is best done if full courses of both drugs is used; diminishing therapy duration means using less than the full course of each drug. The optimum combination regimen is one in which sufficient amounts of both drugs are used to have high efficacy, yet the amounts are as low as possible to spare patients unnecessarily long courses of drug.

In the present protocol, the combination of a half-course of miltefosine and a half-course of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the combination was additive to mildly synergistic against a standard leishmania strain.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Drug: Miltefosine and antimony Drug: Miltefosine alone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Bolivian Cutaneous Leishmaniasis With a Combination of Short Courses of Miltefosine and Antimony
Study Start Date : March 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine

Arm Intervention/treatment
Experimental: Miltefosine and Antimony
Miltefosine 1,5 to 2,5 mg x k x d during 14 days simultaneously with meglumine antimoniate 20 mg x kg x d during 10 days
Drug: Miltefosine and antimony
Short course (half of each drug) administered simultaneously

Active Comparator: Miltefosine alone
Miltefosine 1,5 to 2,5 mg x kg x d during 14 days
Drug: Miltefosine alone
short course (half)

Primary Outcome Measures :
  1. Healing of ulcers [ Time Frame: 45 days ]

Secondary Outcome Measures :
  1. Clinical findings and Laboratory parameters in normal ranges [ Time Frame: 28 days ]

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Parasitological confirmation
  • at least 1 lesion must be ulcerative
  • No specific antileishmanial therapy during the previous six months

Exclusion Criteria:

  • Concomitant diseases such as Tuberculosis, HIV, diabetes, renal failure, liver disease
  • abnormalities CTC 2 in blood, liver, kidney test or EKG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01380301

Hospital Local
La Paz, Bolivia
Sponsors and Collaborators
Foundation Fader
AB Foundation
Study Director: JONATHAN BERMAN, MD, PhD AB Foundation

Responsible Party: JAIME SOTO, Foundation Fader Identifier: NCT01380301     History of Changes
Other Study ID Numbers: 2007-Bol-01
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Foundation Fader:

Additional relevant MeSH terms:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents