Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

This study has been completed.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministerio de Ciencia e Innovación, Spain
Ministério da Saúde
Zentaris Gmb H
Information provided by:
Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT00600548
First received: January 2, 2008
Last updated: April 14, 2010
Last verified: March 2010
  Purpose

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®).


Condition Intervention Phase
Treatment of Cutaneous Leishmaniasis in Brazil.
Drug: Miltefosine.
Drug: Meglumine antimoniate.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • Cure rate or complete cicatrization of the ulcer. [ Time Frame: 6 months after treatment. ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: 2 months after treatment. ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 180
Study Start Date: July 2007
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.1
Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
Drug: Miltefosine.
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.
Other Name: Impavido.
Active Comparator: 1.2
Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
Drug: Meglumine antimoniate.
Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
Other Name: Glucantime.
Experimental: 2.1
Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
Drug: Miltefosine.
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.
Other Name: Impavido.
Active Comparator: 2.2
Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).
Drug: Meglumine antimoniate.
Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
Other Name: Glucantime.

  Eligibility

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600548

Locations
Brazil
Fundação de Medicina Tropical do Amazonas
Manaus, Amazonas, Brazil
Posto de Saúde de Corte de Pedra
Tancredo Neto, Bahia, Brazil
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministerio de Ciencia e Innovación, Spain
Ministério da Saúde
Zentaris Gmb H
Investigators
Principal Investigator: Paulo RL Machado, MD, PhD Federal University of Bahia
  More Information

No publications provided by Hospital Universitário Professor Edgard Santos

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paulo Roberto Lima Machado, Universidade Federal da Bahia
ClinicalTrials.gov Identifier: NCT00600548     History of Changes
Other Study ID Numbers: D-18506, 410559/2006-7
Study First Received: January 2, 2008
Last Updated: April 14, 2010
Health Authority: Brazil: Universidade Federal da Bahia
Brazil: Fundação de Medicina Tropical do Amazonas
Brazil: Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
Brazil: Ministério da Ciência e Tecnologia

Keywords provided by Hospital Universitário Professor Edgard Santos:
Cutaneous leishmaniasis
Miltefosine
Meglumine antimoniate
L. braziliensis, L. guyanensis

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Miltefosine
Meglumine
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals
Antifungal Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014