Short Course of Miltefosine and Antimony to Treat Cutaneous Leishmaniasis in Bolivia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Until recently, the standard treatment for the leishmaniases was pentavalent antimony (Glucantime or Pentostam). The cure rate for L panamensis in Colombia is 91%-93% \[Soto, 1993; Velez, 1997\] and the cure rate in Bolivia, in work soon to be completed, is also 90% \[ Soto, unpublished results\]. A large study with several formulations of antimony found a combined Bolivia-Colombia cure rate of 86% \[Soto, 2004b\]. Nevertheless, pentavalent antimonials have the disadvantages of multiple injections and mild-moderate clinical toxicity \[gastrointestinal complaints, liver enzyme elevations, pancreatic enzyme elevations\], 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. In Colombia, the cure rate for miltefosine was 91% \[Soto 2004a\] and in the soon to be completed comparative trial in Bolivia, the cure rate for miltefosine appears to be 92% \[Soto, unpublished results\]. 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 \[Soto 2001; Soto 2004\]. A further disadvantage of miltefosine is that regimens shorter than 4 weeks have not been evaluated for cutaneous disease.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cutaneous Leihmaniasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Leishmaniasis Cutaneous leishmaniasis Miltefosine Glucantime Antimony Pentavalent antimonials Combination therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Miltefosine , meglumine antimoniate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Gender: Male Age: Adults Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion.

Exclusion Criteria

* Previous treatment for leishmaniasis, specific or putatively specific therapy (Sb, pentamidine, amphotericin B, imidazoles, allopurinol)
* Other concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT), values of pancreatic function (lipase), kidney function tests (creatinine), and EKG.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan Berman, MD, PhD

Role: STUDY_CHAIR

AB Foundation for Medical Research

Jorge Vargas, MD

Role: PRINCIPAL_INVESTIGATOR

Cenetrop

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Dermatológico

Jorochito, Santa Cruz Department, Bolivia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Bolivia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jaime Soto, MD

Role: CONTACT

Phone: 571 348 2171

Email: [email protected]

Julia Toledo, MD