Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony

NCT01380301 | Terminated Phase 2

• 1 other identifier: 2007-Bol-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis

Keywords

Leishmaniasis; Miltefosine; Antimony; Therapy

Outcome Measures

Primary Outcomes (1)

• Healing of ulcers

  45 days

Secondary Outcomes (1)

• Clinical findings and Laboratory parameters in normal ranges

  28 days

Study Arms (2)

Miltefosine and Antimony

EXPERIMENTAL

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

Miltefosine alone

ACTIVE COMPARATOR

Miltefosine 1,5 to 2,5 mg x kg x d during 14 days

Drug: Miltefosine alone

Interventions

Miltefosine and antimony DRUG

Short course (half of each drug) administered simultaneously

Miltefosine and Antimony

Miltefosine alone DRUG

short course (half)

Miltefosine alone

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Foundation Fader: lead
• AB Foundation: collaborator

Study Sites (1)

Hospital Local

La Paz, La Paz Department, Bolivia

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Leishmaniasis

Interventions

miltefosine; Antimony

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metalloids; Elements; Inorganic Chemicals; Metals, Heavy; Metals

Study Officials

• JONATHAN BERMAN, MD, PhD

  AB Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: June 27, 2011
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2009
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

BO (1)