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

University of Brasilia

Status and phase: Completed; Phase 4

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Meglumine antimoniate

Study type: Interventional

Funder types: Other

Identifiers

NCT00317980

NMT-LD-CP-2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 7 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Low dose

Experimental group

Description:

Meglumine antimoniate 5 mg/kg/d for 20 days

Treatment:

Drug: Meglumine antimoniate

Drug: Meglumine antimoniate

Standard dose

Active Comparator group

Description:

Meglumine antimoniate 15 mg/kg/d for 20 days

Treatment:

Drug: Meglumine antimoniate

Drug: Meglumine antimoniate