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

Phase 4

Completed

• Conditions: Localized Cutaneous Leishmaniasis
• Interventions: Drug: Meglumine antimoniate

• Registration Number: NCT00818818
• Lead Sponsor: University of Brasilia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-08
• Primary Completion: 2010-01
• Study Completion: 2010-04
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-07
• Last Update Posted: 2010-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Health Center Unit of Corte de Pedra; 🇧🇷 Corte de Pedra, Presidente Tancredo Neves, Bahia State, Brazil