Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis (Lowdosesb)

January 20, 2009 updated by: University of Brasilia

Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis

The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent. Recently, some research developed in Brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen. That evidence has been obtained in patients from the State of Rio de Janeiro who were infected by Leishmania (Viannia) braziliensis. The purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by Leishmania (Viannia) braziliensis living in a rural area of the State of Bahia, Brazil, where cutaneous leishmaniasis is highly endemic. The usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs.

The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes:

  • Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 5 mg/kg/d intravenous for 20 days
  • Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 15 mg/kg/d intravenous for 20 days

The clinical outcomes of cure or failure will be evaluated until the third month of follow-up.

Study Type

Interventional

Enrollment (Actual)

280

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
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70904-970
        • Núcleo de Medicina Tropical, University of Brasilia

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

7 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis
  • Disease duration of 2 to 20 weeks
  • Positive leishmanin skin test
  • Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp

Exclusion Criteria:

  • History of past episode of leishmaniasis
  • Mucosal disease
  • Disseminated disease
  • Use of drugs with anti-leishmanial activity

  • Contraindications for using pentavalent antimony:

    • pregnancy
    • renal failure
    • heart failure
    • hepatic failure

  • Other diseases:

    • active tuberculosis
    • hanseniasis

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low dose
Meglumine antimoniate 5 mg/kg/d for 20 days
Drug: Meglumine antimoniate
Meglumine antimoniate 5mg/kg/d for 20 days
Other Names:
  • Glucantime
Drug: Meglumine antimoniate
Meglumine antimoniate 15 mg/kg/d for 20 days
Other Names:
  • Glucantime
ACTIVE_COMPARATOR: Standard dose
Meglumine antimoniate 15 mg/kg/d for 20 days
Drug: Meglumine antimoniate
Meglumine antimoniate 5mg/kg/d for 20 days
Other Names:
  • Glucantime
Drug: Meglumine antimoniate
Meglumine antimoniate 15 mg/kg/d for 20 days
Other Names:
  • Glucantime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of clinically cured patients at the third month after treatment
Time Frame: Three months after treatment
Three months after treatment
Proportion of patients with epithelialized lesions
Time Frame: Three months after treatment
Three months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with adherence to the protocol prescribed drug
Time Frame: 30 days
30 days
Proportion of patients with adverse events
Time Frame: 30 days after treatment
30 days after treatment
Proportion of patients with late failure after the first three months of follow-up
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

University of Brasilia

Collaborators

Ministry of Health, Brazil

Investigators

  • Principal Investigator: Gustavo S Romero, MD, University of Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2006

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

April 21, 2006

First Submitted That Met QC Criteria

April 21, 2006

First Posted (ESTIMATE)

April 25, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMT-LD-CP-2006

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.

Clinical Trials on Cutaneous Leishmaniasis

Clinical Trials on Meglumine antimoniate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe