Localized Cutaneous Leishmaniasis
Conditions
Keywords
Leishmaniasis, Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimonial, Glucantime
Brief summary
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.
Interventions
5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days
Sponsors
University of Brasilia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure | Three months after treatment | Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events rate - day 7 | 7th day | 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 |
| Adverse events rate - day 14 | 14th day | 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 |
| Total Adverse events rate | 20th day | Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the whole treatment |
Countries
Brazil
Outcome results
None listed