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Sponsored by: |
Hospital Universitário Professor Edgard Santos |
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Information provided by: | Hospital Universitário Professor Edgard Santos |
ClinicalTrials.gov Identifier: | NCT00469495 |
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 |
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Leishmaniasis, Cutaneous Helminthiasis |
Drug: Anti-helminthic Drug: meglumine antimony |
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 |
Estimated Enrollment: | 90 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | August 2007 |
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.
Ages Eligible for Study: | 13 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Edgar M Carvalho, MD | 212-746-6320 | edgar@ufba.br |
Contact: Marshall J Glesby, MD, PhD | 212-746-6320 | mag2005@med.cornell.edu |
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 |
Principal Investigator: | Edgar M Carvalho, MD | Universidade Federal da Bahia |
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 |
Leishmaniasis Protozoan Infections Skin Diseases, Infectious Skin Diseases |
Anthelmintics Parasitic Diseases Leishmaniasis, Cutaneous Helminthiasis |
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 |