Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony

This study has been terminated.
(Low efficacy rates)
Sponsor:
Collaborator:
AB Foundation
Information provided by:
Foundation Fader
ClinicalTrials.gov Identifier:
NCT01380301
First received: January 28, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Cutaneous Leishmaniasis
Drug: Miltefosine and antimony
Drug: Miltefosine alone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Bolivian Cutaneous Leishmaniasis With a Combination of Short Courses of Miltefosine and Antimony

Resource links provided by NLM:


Further study details as provided by Foundation Fader:

Primary Outcome Measures:
  • Healing of ulcers [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical findings and Laboratory parameters in normal ranges [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: March 2007
Study Completion Date: January 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380301

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

No publications provided

Responsible Party: JAIME SOTO, Foundation Fader
ClinicalTrials.gov Identifier: NCT01380301     History of Changes
Other Study ID Numbers: 2007-Bol-01
Study First Received: January 28, 2009
Last Updated: June 22, 2011
Health Authority: Bolivia: Ethics Committee
Bolivia: Ministry of Health

Keywords provided by Foundation Fader:
Leishmaniasis
Miltefosine
Antimony
Therapy

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

ClinicalTrials.gov processed this record on April 23, 2014