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Miltefosine and GM-CSF in Cutaneous Leishmaniasis

NCT03023111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-04-07

No results posted yet for this study

Summary

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.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

Sbv

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

DRUG

Miltefosine plus placebo

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

DRUG

Miltefosine plus GM-CSF

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

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Hospital Universitário Professor Edgard Santos

    lead OTHER

Principal Investigators

  • Paulo RL Machado, MD, PhD · Federal University of Bahia

  • Edgar M Carvalho, MD, PhD · Instituto Fernandes Figueira

  • Manoel Barral Neto, MD, PhD · Instituto Fernandes Figueira

  • Gerson Penna, MD, PhD · Instituto Fernandes Figueira

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2019-08-09
Completion
2020-02-14

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03023111 on ClinicalTrials.gov