Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis

Helminthiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469495
• Other study ID #: 0701008939
• Status: Completed
• Phase: N/A
• First received: May 2, 2007
• Last updated: August 25, 2009
• Start date: February 2007
• Est. completion date: November 2008

Study information

• Verified date: August 2009
• Source: Hospital Universitário Professor Edgard Santos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helminthiasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• Anti-helminthic

• meglumine antimony

Locations

Country	Name	City	State
Brazil	Posto de Saude de Corte de Pedra	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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