Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 2, 2007
CompletedFirst Posted
Study publicly available on registry
May 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedAugust 26, 2009
August 1, 2009
1.6 years
May 2, 2007
August 25, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Bidirectional measurements will be taken of the subjects' lesions at each visit and will be categorized as active or healed by a dermatologist.
90 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Posto de Saude de Corte de Pedra
Salvador, Estado de Bahia, Brazil
Related Publications (1)
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.
PMID: 21460008DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edgar M Carvalho, MD
Federal University of Bahia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 2, 2007
First Posted
May 4, 2007
Study Start
February 1, 2007
Primary Completion
September 1, 2008
Study Completion
November 1, 2008
Last Updated
August 26, 2009
Record last verified: 2009-08