Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients (Sbold)

University of Brasilia

Status and phase: Completed; Phase 4

Conditions: Localized Cutaneous Leishmaniasis

Treatments: Drug: Meglumine antimoniate

Study type: Interventional

Funder types: Other

Identifiers

NCT00818818

lowdoseaging

Details and patient eligibility

About

This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.

Enrollment: 13 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 65 years
• Permanent residence in the endemic area
• Availability of a caregiver for dependent patients

Exclusion criteria

• Mucosal disease caused by leishmaniasis
• Disseminated cutaneous disease
• Severe cardiac, renal or hepatic disorders
• Active cancer
• Active tuberculosis
• Leprosy
• HIV positive
• Total bilirubin > 1.5mg/dL
• Urea and creatinin > 1.5 times the upper normal level
• Alkaline phosphatase and aminotransferases > 2.5 times the upper normal level
• Lipase and amylase > 1.5 the upper normal level
• Hemoglobin < 5 g/dL of

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Meglumine antimoniate

Experimental group

Description:

Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days.

Treatment:

Drug: Meglumine antimoniate