Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT00469495
First received: May 2, 2007
Last updated: August 25, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention
Leishmaniasis, Cutaneous
Helminthiasis
Drug: Anti-helminthic
Drug: meglumine antimony

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: February 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00469495

Locations
Brazil
Posto de Saude de Corte de Pedra
Salvador, Bahia, Brazil
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Investigators
Principal Investigator: Edgar M Carvalho, MD Federal University of Bahia
  More Information

No publications provided by Hospital Universitário Professor Edgard Santos

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edgar M. Carvalho, Universidade Federal da Bahia
ClinicalTrials.gov Identifier: NCT00469495     History of Changes
Other Study ID Numbers: 0701008939
Study First Received: May 2, 2007
Last Updated: August 25, 2009
Health Authority: Brazil: National Committee of Ethics in Research
United States: Institutional Review Board

Additional relevant MeSH terms:
Helminthiasis
Leishmaniasis
Leishmaniasis, Cutaneous
Parasitic Diseases
Euglenozoa Infections
Protozoan Infections
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014