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NCT Number: NCT03023111

Miltefosine and GM-CSF in Cutaneous Leishmaniasis

Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been described in up to 50% of patients, and the long period of 60 to 90 days required for healing of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited either by toxicity or because, as with Sbv, the parenteral route hinders adherence and regularity of treatment in the rural area. Recent studies by our group indicate that oral miltefosine is the most effective drug for the treatment of patients with CL caused by L. (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75% respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L. (V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundação de Medicina Tropical do Amazonas, Manaus, Amazonas, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Untreated ulcerative cutaneous leishmaniasis, with laboratory diagnosis obtained through at least one of the following tests: direct examination of the lesion, positive culture or PCR for Leishmania.
  • Age: 18 to 65 years;
  • Sex: male and female patients;
  • Presence of at least 1 ulcerated lesion at any location;
  • Presence of a maximum of 3 ulcerated lesions;
  • Diameter of lesions varying between 1 and 5 cm;
  • Clinical evolution of the disease of not less than 1 month and not more than 3 months.

Exclusion criteria

  • Evidence of severe underlying disease (cardiac, renal, hepatic, pulmonary) or malignant disease;
  • Patients with immunodeficiency or HIV carriers;
  • Serious protein and / or caloric malnutrition;
  • Active and uncontrolled infectious-contagious disease such as tuberculosis, leprosy, systemic fungal disease (histoplasmosis, paracoccidioidomycosis) or any other similar condition;
  • Women who are pregnant or breastfeeding;
  • Allergy to Sbv or miltefosine;
  • Previous treatment for leishmaniasis;
  • Lack of capacity or willingness to provide informed consent (patient and / or parent / legal representative); Absence of availability for the visits or to comply with the study procedures.

Treatment and study plan

Sbv

Drug

Standard treatment for CL, parenteral drug used during 20 days.

Other names: Glucantime

Miltefosine plus placebo

Drug

Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. Placebo gel cream will be used topically.

Other names: Impavido plus placebo

Miltefosine plus GM-CSF

Drug

Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. GM-CSF gel cream will be used topically.

Other names: Impavido plus GM-CSF

Primary outcomes

  1. Final cure rate or complete cicatrization of the ulcer

    Time frame: 6 months after the end of treatment

    All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.

Secondary outcomes

  1. Initial cure rate or initial cicatrization of the ulcer

    Time frame: 2 months after the end of treatment

    All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.

  2. Healing time

    Time frame: Up to 2 months after the end of treatment

    Time (in days) to achieve complete cicatrization will be recorded.

  3. Clinical and laboratory adverse events

    Time frame: During treatment and through study completion, an average of 1 year

    Clinical and laboratory adverse events will be recorded and graded according to the Common Terminology Criteria for Adverse Event (CTCAE) of the National Cancer Institute

Sponsors and collaborators

Lead sponsor

Hospital Universitário Professor Edgard Santos

Other

Collaborators

  • Oswaldo Cruz Foundation

Registry information

Official study title

Miltefosine and GM-CSF in Cutaneous Leishmaniasis: a Randomized and Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 18, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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