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Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
This study is currently recruiting participants.
Verified by Hospital Universitário Professor Edgard Santos, May 2007
First Received: May 2, 2007   No Changes Posted
Sponsored by: Hospital Universitário Professor Edgard Santos
Information provided by: Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier: NCT00469495
  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

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Meglumine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date: August 2007
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469495

Contacts
Contact: Edgar M Carvalho, MD 212-746-6320 edgar@ufba.br
Contact: Marshall J Glesby, MD, PhD 212-746-6320 mag2005@med.cornell.edu

Locations
Brazil, Bahia
Posto de Saude de Corte de Pedra Recruiting
Salvador, Bahia, Brazil
Sub-Investigator: Luiz HS Guimaraes, MD            
Sub-Investigator: Tracey Newlove, BA, BS            
Sub-Investigator: Paulo RL Machado, MD            
Sub-Investigator: Albert Schriefer, PhD            
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Investigators
Principal Investigator: Edgar M Carvalho, MD Universidade Federal da Bahia
  More Information

No publications provided

Study ID Numbers: 0701008939
Study First Received: May 2, 2007
Last Updated: May 2, 2007
ClinicalTrials.gov Identifier: NCT00469495     History of Changes
Health Authority: Brazil: National Committee of Ethics in Research;   United States: Institutional Review Board

Study placed in the following topic categories:
Leishmaniasis
Protozoan Infections
Skin Diseases, Infectious
Skin Diseases
Anthelmintics
Parasitic Diseases
Leishmaniasis, Cutaneous
Helminthiasis

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

ClinicalTrials.gov processed this record on May 06, 2009