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

October 7, 2010 updated by: University of Brasilia

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia State
      • Corte de Pedra, Presidente Tancredo Neves, Bahia State, Brazil, 45416 - 000
        • Health Center Unit of Corte de Pedra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meglumine antimoniate
Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days.
Drug: Meglumine antimoniate
5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days
Other Names:
  • Glucantime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure
Time Frame: Three months after treatment
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
Time Frame: 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
7th day
Adverse events rate - day 14
Time Frame: 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
14th day
Total Adverse events rate
Time Frame: 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
20th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Investigators

  • Principal Investigator: Julia S Ampuero-Vela, MD, MSc, Faculty of Medicine, University of Brasilia
  • Study Chair: Gustavo Adolfo S Romero, MD, PhD, Faculty of Medicine, University of Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 8, 2010

Last Update Submitted That Met QC Criteria

October 7, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lowdoseaging

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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