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Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis (Lowdosesb)

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ClinicalTrials.gov Identifier: NCT00317980
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : January 22, 2009
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by:
University of Brasilia

Brief Summary:
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Drug: Meglumine antimoniate Phase 4

Detailed Description:

The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent. Recently, some research developed in Brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen. That evidence has been obtained in patients from the State of Rio de Janeiro who were infected by Leishmania (Viannia) braziliensis. The purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by Leishmania (Viannia) braziliensis living in a rural area of the State of Bahia, Brazil, where cutaneous leishmaniasis is highly endemic. The usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs.

The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes:

  • Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 5 mg/kg/d intravenous for 20 days
  • Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 15 mg/kg/d intravenous for 20 days

The clinical outcomes of cure or failure will be evaluated until the third month of follow-up.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis
Study Start Date : February 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Meglumine

Arm Intervention/treatment
Experimental: Low dose
Meglumine antimoniate 5 mg/kg/d for 20 days
Drug: Meglumine antimoniate
Meglumine antimoniate 5mg/kg/d for 20 days
Other Name: Glucantime

Active Comparator: Standard dose
Meglumine antimoniate 15 mg/kg/d for 20 days
Drug: Meglumine antimoniate
Meglumine antimoniate 15 mg/kg/d for 20 days
Other Name: Glucantime




Primary Outcome Measures :
  1. Proportion of clinically cured patients at the third month after treatment [ Time Frame: Three months after treatment ]
  2. Proportion of patients with epithelialized lesions [ Time Frame: Three months after treatment ]

Secondary Outcome Measures :
  1. Proportion of patients with adherence to the protocol prescribed drug [ Time Frame: 30 days ]
  2. Proportion of patients with adverse events [ Time Frame: 30 days after treatment ]
  3. Proportion of patients with late failure after the first three months of follow-up [ Time Frame: 12 months ]


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Ages Eligible for Study:   7 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis
  • Disease duration of 2 to 20 weeks
  • Positive leishmanin skin test
  • Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp

Exclusion Criteria:

  • History of past episode of leishmaniasis
  • Mucosal disease
  • Disseminated disease
  • Use of drugs with anti-leishmanial activity
  • Contraindications for using pentavalent antimony:

    • pregnancy
    • renal failure
    • heart failure
    • hepatic failure
  • Other diseases:

    • active tuberculosis
    • hanseniasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317980


Locations
Brazil
Núcleo de Medicina Tropical, University of Brasilia
Brasilia, Distrito Federal, Brazil, 70904-970
Sponsors and Collaborators
University of Brasilia
Ministry of Health, Brazil
Investigators
Principal Investigator: Gustavo S Romero, MD University of Brasilia

Publications:
Responsible Party: Gustavo S Romero MD, Nucleo de Medicina Tropical, University of Brasilia
ClinicalTrials.gov Identifier: NCT00317980     History of Changes
Other Study ID Numbers: NMT-LD-CP-2006
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by University of Brasilia:
Cutaneous leishmaniasis
Leishmania braziliensis
Pentavalent antimony
Meglumine antimoniate

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents