An interventional study of Anti-helminthic and meglumine antimony in Leishmaniasis, Cutaneous and Helminthiasis, sponsored by Hospital Universitário Professor Edgard Santos. Completed at 1 site in Brazil. Open to participants aged 13 Years to 50 Years. Per ClinicalTrials.gov, last updated 2009-08-26.
Sponsored by Hospital Universitário Professor Edgard Santos · Not applicable, Interventional, and Treatment
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.
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.
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 133 interventional studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →Hospital Universitário Professor Edgard Santos is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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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
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Hospital Universitário Professor Edgard Santos