Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony

Cutaneous Leishmaniasis Clinical Trial

Official title:

Treatment of Bolivian Cutaneous Leishmaniasis With a Combination of Short Courses of Miltefosine and Antimony

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01380301
• Other study ID #: 2007-Bol-01
• Status: Terminated
• Phase: Phase 2
• First received: January 28, 2009
• Last updated: June 22, 2011
• Start date: March 2007
• Est. completion date: January 2009

Study information

• Verified date: June 2011
• Source: Foundation Fader
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bolivia: Ethics CommitteeBolivia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• Miltefosine and antimony
Short course (half of each drug) administered simultaneously
• Miltefosine alone
short course (half)

Locations

Country	Name	City	State
Bolivia	Hospital Local	La Paz

Sponsors (2)

Lead Sponsor	Collaborator
Foundation Fader	AB Foundation

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of ulcers		45 days	Yes
Secondary	Clinical findings and Laboratory parameters in normal ranges		28 days	Yes