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Completed

NCT Number: NCT03445897

Miltefosine Plus IL Pentamidine for Bolivian CL

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • one ulcerative lesion ≤ 900 mm2 in total area,
  • ≥ 12 years,
  • parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
  • no antileishmanial therapy in the last 3 months,
  • no mucosal lesions,
  • no history of significant concomitant diseases including immunosuppression.

Exclusion criteria

Treatment and study plan

miltefosine plus intralesional pentamidine

Drug

miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Primary outcomes

  1. Lesion size

    Time frame: 6 months post therapy

    area of lesion

Secondary outcomes

  1. adverse effects at site

    Time frame: days 1, 3, 5 of therapy

    pain, erythema, edema

  2. systemic adverse effects

    Time frame: days 1 to 28 of therapy

    gastrointestinal side effects

Sponsors and collaborators

Lead sponsor

Jonathan Berman

Other

Registry information

Official study title

Miltefosine Combined With Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2018
Registry last updated
Feb 27, 2018

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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