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Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Primary Purpose

Treatment of Cutaneous Leishmaniasis in Brazil.

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Miltefosine.
Meglumine antimoniate.
Miltefosine.
Meglumine antimoniate.
Sponsored by
Hospital Universitário Professor Edgard Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Cutaneous Leishmaniasis in Brazil. focused on measuring Cutaneous leishmaniasis, Miltefosine, Meglumine antimoniate, L. braziliensis, L. guyanensis

Eligibility Criteria

2 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
  • Number of lesions: 1 to 5 ulcerative lesions.
  • Lesion´s diameter: 1 to 5 cm.
  • Disease duration: up to three months.

Exclusion Criteria:

Safety concerns:

  • Thrombocyte count <30 x 109/l
  • Leukocyte count <1 x 109/l
  • Hemoglobin <5 g/100 ml
  • ASAT, ALAT, AP >3 times upper limit of normal range
  • Bilirubin >2 times upper limit of normal range
  • Serum creatinine or BUN >1.5 times upper limit of normal range
  • Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
  • Immunodeficiency or antibody to HIV
  • Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
  • Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months

Lack of suitability for the trial:

  • Negative parasitology (aspirate/smear)or negative Montenegro test
  • Any history of prior anti-leishmania therapy
  • Any condition which compromises ability to comply with the study procedures
  • Concomitant serious infection other than cutaneous

Administrative reasons:

  • Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
  • Anticipated non-availability for study visits/procedures

Sites / Locations

  • Fundação de Medicina Tropical do Amazonas
  • Posto de Saúde de Corte de Pedra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1.1

1.2

2.1

2.2

Arm Description

Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.

Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).

Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.

Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).

Outcomes

Primary Outcome Measures

Cure rate or complete cicatrization of the ulcer.
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. 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.

Secondary Outcome Measures

Inicial cure rate or complete cicatrization of the ulcer.
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. 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.

Full Information

First Posted
January 2, 2008
Last Updated
April 14, 2010
Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministerio de Ciencia e Innovación, Spain, Ministry of Health, Brazil, AEterna Zentaris
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1. Study Identification

Unique Protocol Identification Number
NCT00600548
Brief Title
Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)
Official Title
Clinical Trial to Assess Efficacy and Safety of Orally Administered Miltefosine in Brazilian Patients With Cutaneous Leishmaniasis Compared to the Standard Care as Active Control
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministerio de Ciencia e Innovación, Spain, Ministry of Health, Brazil, AEterna Zentaris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Cutaneous Leishmaniasis in Brazil.
Keywords
Cutaneous leishmaniasis, Miltefosine, Meglumine antimoniate, L. braziliensis, L. guyanensis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.1
Arm Type
Experimental
Arm Description
Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
Arm Title
1.2
Arm Type
Active Comparator
Arm Description
Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
Arm Title
2.1
Arm Type
Experimental
Arm Description
Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
Arm Title
2.2
Arm Type
Active Comparator
Arm Description
Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).
Intervention Type
Drug
Intervention Name(s)
Miltefosine.
Other Intervention Name(s)
Impavido.
Intervention Description
Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate.
Other Intervention Name(s)
Glucantime.
Intervention Description
Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
Intervention Type
Drug
Intervention Name(s)
Miltefosine.
Other Intervention Name(s)
Impavido.
Intervention Description
Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate.
Other Intervention Name(s)
Glucantime.
Intervention Description
Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
Primary Outcome Measure Information:
Title
Cure rate or complete cicatrization of the ulcer.
Description
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. 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.
Time Frame
6 months after treatment.
Secondary Outcome Measure Information:
Title
Inicial cure rate or complete cicatrization of the ulcer.
Description
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. 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.
Time Frame
2 months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test). Number of lesions: 1 to 5 ulcerative lesions. Lesion´s diameter: 1 to 5 cm. Disease duration: up to three months. Exclusion Criteria: Safety concerns: Thrombocyte count <30 x 109/l Leukocyte count <1 x 109/l Hemoglobin <5 g/100 ml ASAT, ALAT, AP >3 times upper limit of normal range Bilirubin >2 times upper limit of normal range Serum creatinine or BUN >1.5 times upper limit of normal range Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary) Immunodeficiency or antibody to HIV Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months Lack of suitability for the trial: Negative parasitology (aspirate/smear)or negative Montenegro test Any history of prior anti-leishmania therapy Any condition which compromises ability to comply with the study procedures Concomitant serious infection other than cutaneous Administrative reasons: Lack of ability or willingness to give informed consent (patient and/or parent / legal representative) Anticipated non-availability for study visits/procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo RL Machado, MD, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundação de Medicina Tropical do Amazonas
City
Manaus
State/Province
Amazonas
Country
Brazil
Facility Name
Posto de Saúde de Corte de Pedra
City
Tancredo Neto
State/Province
Bahia
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21200420
Citation
Machado PR, Ampuero J, Guimaraes LH, Villasboas L, Rocha AT, Schriefer A, Sousa RS, Talhari A, Penna G, Carvalho EM. Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. PLoS Negl Trop Dis. 2010 Dec 21;4(12):e912. doi: 10.1371/journal.pntd.0000912.
Results Reference
derived

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Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

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