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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days
Health Center Unit of Corte de Pedra
Corte de Pedra, Presidente Tancredo Neves, Bahia State, Brazil
Clinical cure
Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)
Time frame: Three months after treatment
Adverse events rate - day 7
Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the first week of treatment
Time frame: 7th day
Adverse events rate - day 14
Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the second week of treatment
Time frame: 14th day
Total Adverse events rate
Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the whole treatment
Time frame: 20th day
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