Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis

August 25, 2009 updated by: Hospital Universitário Professor Edgard Santos

Empiric Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis: A Randomized Controlled Trial in Subjects Co-Infected With Helminths and Leishmania Brasiliensis

The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic therapy combined with standard pentavalent antimony in the treatment of subjects co-infected with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is that early intervention with antihelminthic therapy will improve response rates to antimony in subjects with cutaneous leishmaniasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Leishmaniases are a group of diseases caused by a parasite and transmitted by the sand fly. There are a number of diseases associated with infection ranging from simple skin lesions to a severe, fatal form. The standard treatment of cutaneous leishmaniasis (CL) is a 20 day course of antimony which, although fairly effective, has multiple side effects and is difficult to administer. The populations that are affected by leishmaniasis are usually also affected by intestinal helminths (worms). It is unknown what effect these two diseases have on each other and the immune system. As pathology in CL is mediated by an inflammatory reaction and helminths down regulate inflammation, helminthic infection may be beneficial for leishmaniasis. However, a recent study by our research group suggested that subjects infected with both leishmania and helminths have longer healing times and are less likely to respond to antimony. Since failure of initial therapy often results in repeat courses of the drug or development of more severe disease, we propose a study to investigate the role of early treatment for co-existing helminth infections in improving response rates to antimony in subjects with CL.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

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
      • Salvador, Bahia, Brazil
        • Posto de Saúde de 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

13 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with a diagnosis of CL based on the presence of typical skin lesions and a positive Montenegro skin test
  • Evidence of helminthic infection by parasitological examination of first stool sample
  • Males or females between 13 and 50 years of age
  • Maximum of 3 ulcers with no more than 2 body regions involved
  • Period of 15 to 60 days from the onset of the first ulcer
  • Subject agreement to follow-up visits and therapy
  • Ability to give informed consent

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding mothers
  • Presence of mucosal disease
  • History of prior treatment with antimonial drugs.
  • History of prior treatment with anthelminthic drugs within the last 6 months.
  • History of allergy to pentavalent antimony or antihelminthic
  • Presence of underlying disease which affects the immune response, such as HIV and diabetes mellitus

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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bidirectional measurements will be taken of the subjects' lesions at each visit and will be categorized as active or healed by a dermatologist.
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Hospital Universitário Professor Edgard Santos

Investigators

  • Principal Investigator: Edgar M Carvalho, MD, Federal University of Bahia

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, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 2, 2007

First Submitted That Met QC Criteria

May 2, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

August 26, 2009

Last Update Submitted That Met QC Criteria

August 25, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0701008939

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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