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

NCT ID: NCT00818818

Last Updated: 2010-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-04-30

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.

Detailed Description

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Conditions

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Localized Cutaneous Leishmaniasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meglumine antimoniate

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

Group Type EXPERIMENTAL

Meglumine antimoniate

Intervention Type DRUG

5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days

Interventions

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Meglumine antimoniate

5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days

Intervention Type DRUG

Other Intervention Names

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Glucantime

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Brasilia

OTHER

Sponsor Role lead

Responsible Party

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Faculty of Medicine, University of Brasilia

Principal Investigators

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Julia S Ampuero-Vela, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Brasilia

Gustavo Adolfo S Romero, MD, PhD

Role: STUDY_CHAIR

Faculty of Medicine, University of Brasilia

Locations

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Health Center Unit of Corte de Pedra

Corte de Pedra, Presidente Tancredo Neves, Bahia State, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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lowdoseaging

Identifier Type: -

Identifier Source: org_study_id