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

Study Overview
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Brief Summary
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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.

Official Title
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Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial.

Conditions
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Localized Cutaneous Leishmaniasis

Intervention / Treatment
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* Drug: Meglumine antimoniate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meglumine antimoniate<br>Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days. | Drug: Meglumine antimoniate<br>* 5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days<br>* Other names: Glucantime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure | Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation) | Three months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 20th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leishmaniasis, Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimonial, Glucantime