Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
Primary Purpose
Leishmaniasis, Cutaneous, Helminthiasis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Anti-helminthic
meglumine antimony
Sponsored by
About this trial
This is an interventional treatment trial for Leishmaniasis, Cutaneous
Eligibility 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
Sites / Locations
- Posto de Saude de Corte de Pedra
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00469495
First Posted
May 2, 2007
Last Updated
August 25, 2009
Sponsor
Hospital Universitário Professor Edgard Santos
1. Study Identification
Unique Protocol Identification Number
NCT00469495
Brief Title
Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
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 Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitário Professor Edgard Santos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis, Cutaneous, Helminthiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anti-helminthic
Intervention Type
Drug
Intervention Name(s)
meglumine antimony
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar M Carvalho, MD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Posto de Saude de Corte de Pedra
City
Salvador
State/Province
Bahia
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
21460008
Citation
Newlove T, Guimaraes LH, Morgan DJ, Alcantara L, Glesby MJ, Carvalho EM, Machado PR. Antihelminthic therapy and antimony in cutaneous leishmaniasis: a randomized, double-blind, placebo-controlled trial in patients co-infected with helminths and Leishmania braziliensis. Am J Trop Med Hyg. 2011 Apr;84(4):551-5. doi: 10.4269/ajtmh.2011.10-0423.
Results Reference
derived
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Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
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