Th1/Th2 Polarization and Linkage to L. Viannia Infection Outcomes

NCT00401297 | Completed DMC

• 2 other identifiers: 0608001741U19AI065866
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine what types of cells participate in the defense of humans against Leishmania (skin parasites). People 18-70 years of age who have leishmaniasis, have healed leishmanial lesions, or are healthy are being invited to participate in this study. Approximately 150 people will participate in the study. Participants will be asked to provide some general information about themselves and about skin sores, if they have any. A skin test will be performed and a blood sample will be obtained. This study involves up to 3 visits; the first visit will last up to 5 hours and the second visit will last for 30 minutes. The third visit may be scheduled within 3 days after the second visit.

Conditions

Leishmaniasis

Keywords

Leishmaniasis; L. Viannia; Leishmania; Colombia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Age between 18-70 years 1. Historical and confirmed cases of chronic leishmaniais disease with no current leishmaniasis 2. Historical cases of confirmed recurrent leishmaniasis disease 3 Asymptomatic infection cases: (Resident of endemic area, PBMCs responsive to leishmanial antigen) 4\. Healthy donors: * No history or evidence of exposure to transmission of leishmaniasis

You may qualify if:

• All Groups:
• \- Age between 18-70 years
• Historical cases of chronic disease:
• Historic parasitologically confirmed, skin test positive CL patients who presented chronic CL lesions of \> 6 months duration at the time of diagnosis.
• No active lesions
• Voluntary participation in the study
• Informed consent for HIV testing and participation in the study
• Historical cases of recurrent disease:
• Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
• No active lesions
• Voluntary participation in the study
• Informed consent for HIV testing and participation in the study
• Asymptomatic infection cases:
• Resident of endemic area
• PBMCs responsive to leishmanial antigen in culture

You may not qualify if:

• Immunosuppressive disease
• Pharmacotherapy with drugs that are immunosuppressive
• Allergy/sensitivity to lidocaine family anesthetics or to latex
• Pregnancy
• Breastfeeding
• Unwillingness to participate

Sponsors & Collaborators

• Yale University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Centro Internacional de Entrenamiento e Investigaciones Medicas, CIDEIM

Cali, Colombia

Location

MeSH Terms

Conditions

Leishmaniasis

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nancy Gore Saravia, Ph.D.

  CIDEIM, Cali Colombia

  STUDY DIRECTOR

• Diane McMahon-Pratt, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 20, 2006
• Study Start: December 1, 2006
• Study Completion: April 1, 2010
• Last Updated: March 30, 2020

Record last verified: 2011-08

Locations

CO (1)