Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469495
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : August 26, 2009
Information provided by:
Hospital Universitário Professor Edgard Santos

Brief Summary:
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 or disease Intervention/treatment Phase
Leishmaniasis, Cutaneous Helminthiasis Drug: Anti-helminthic Drug: meglumine antimony Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00469495

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Edgar M. Carvalho, Universidade Federal da Bahia Identifier: NCT00469495     History of Changes
Other Study ID Numbers: 0701008939
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: August 26, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antiparasitic Agents
Anti-Infective Agents