Clinical trial NCT00317980: Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cutaneous Leishmaniasis
Keywords: Cutaneous leishmaniasis
Leishmania braziliensis
Pentavalent antimony
Meglumine antimoniate
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2006-04-25
Enrollment: 280
Sex: ALL
Minimum age (years): 7
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Proportion of clinically cured patients at the third month after treatment
timeFrame: Three months after treatment
measure: Proportion of patients with epithelialized lesions
timeFrame: Three months after treatment
Secondary outcomes:
measure: Proportion of patients with adherence to the protocol prescribed drug
timeFrame: 30 days
measure: Proportion of patients with adverse events
timeFrame: 30 days after treatment
measure: Proportion of patients with late failure after the first three months of follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Núcleo de Medicina Tropical, University of Brasilia
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Gustavo S Romero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens. Pathol Biol (Paris). 1997 Jun;45(6):496-9.
citation: Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. A low-dose antimony treatment in 159 patients with American cutaneous leishmaniasis: extensive follow-up studies (up to 10 years). Am J Trop Med Hyg. 1997 Dec;57(6):651-5. doi: 10.4269/ajtmh.1997.57.651.