Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
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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 |
- 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) |
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 |
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| Brazil | |
| Posto de Saude de Corte de Pedra | |
| Salvador, Bahia, Brazil | |
| 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 May 22, 2013