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

Primary Purpose

Localized Cutaneous Leishmaniasis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Meglumine antimoniate
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Cutaneous Leishmaniasis focused on measuring Leishmaniasis, Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimonial, Glucantime

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Health Center Unit of Corte de Pedra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meglumine antimoniate

Arm Description

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

Outcomes

Primary Outcome Measures

Clinical cure
Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)

Secondary Outcome Measures

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
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
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

Full Information

First Posted
January 6, 2009
Last Updated
October 7, 2010
Sponsor
University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT00818818
Brief Title
Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients
Acronym
Sbold
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Brasilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Cutaneous Leishmaniasis
Keywords
Leishmaniasis, Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimonial, Glucantime

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meglumine antimoniate
Arm Type
Experimental
Arm Description
Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate
Other Intervention Name(s)
Glucantime
Intervention Description
5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days
Primary Outcome Measure Information:
Title
Clinical cure
Description
Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)
Time Frame
Three months after treatment
Secondary Outcome Measure Information:
Title
Adverse events rate - day 7
Description
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
Title
Adverse events rate - day 14
Description
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
Title
Total Adverse events rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia S Ampuero-Vela, MD, MSc
Organizational Affiliation
Faculty of Medicine, University of Brasilia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustavo Adolfo S Romero, MD, PhD
Organizational Affiliation
Faculty of Medicine, University of Brasilia
Official's Role
Study Chair
Facility Information:
Facility Name
Health Center Unit of Corte de Pedra
City
Corte de Pedra, Presidente Tancredo Neves
State/Province
Bahia State
ZIP/Postal Code
45416 - 000
Country
Brazil

12. IPD Sharing Statement

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

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