Mechanisms Relating to the Distinct in Vitro Susceptibility of Human Macrophages to L. Viannia Infection

NCT00401557 | Completed

• 2 other identifiers: 0608001740U19AI065866
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how the body defends itself against Leishmania (Viannia), a parasite that can cause a skin infection and skin sores. Certain cells in the immune system act more aggressively against Leishmania in people with mild Leishmania symptoms than in those who have long-term or recurring symptoms of the disease. Participants in the study will include people who currently have Leishmania infection, people who have had the infection in the past, and people who have never been exposed to the parasite. This study will enroll 220 adults, ages 18 to 70 years, at 3 sites in Colombia. Blood samples will be collected from volunteers at least once during the study. Participants will also undergo HIV testing. Volunteers will participate in up to 2 study visits, scheduled 2-3 weeks apart.

Conditions

Leishmaniasis

Keywords

Leishmaniasis, Leishmania (Viannia), 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

Historical cases of chronic disease: * Age between 18-70 years * Historic parasitologically confirmed, skin test positive cutaneous leishmaniasis (CL) patients who presented chronic CL lesions of \> 6 months duration at the time of diagnosis * No active lesions Historical cases of recurrent disease: * Age between 18-70 years * Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease * No active lesions Asymptomatic infection: * Age between 18-70 years * Resident of endemic area * No history or evidence of active or prior dermal leishmaniasis Healthy donors: * Age between 18-70 years * No history or evidence of exposure to transmission of leishmaniasis

You may qualify if:

• For specific objectives 1, 3 and 4:
• Historical cases of chronic disease:
• Age between 18-70 years
• Historic parasitologically confirmed, skin test positive cutaneous leishmaniasis (CL) patients who presented chronic CL lesions of \> 6 months duration at the time of diagnosis
• No active lesions
• Voluntary participation in the study
• Written and signed Informed consent for HIV testing and participation in the study
• Historical cases of recurrent disease:
• Age between 18-70 years
• Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
• No active lesions
• Voluntary participation in the study
• Written and signed Informed consent for HIV testing and participation in the study
• Asymptomatic infection:
• Age between 18-70 years

You may not qualify if:

• Immunosuppressive disease
• Pharmacotherapy with drugs that are immunosuppressive
• Pregnancy
• Breastfeeding
• Unwillingness to participate
• Weight below 50kg
• Immunosuppressive disease (HIV)
• Treatment with drugs that are immunosuppressive
• Pregnancy
• Breastfeeding

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 Saravia, Ph.D.

  Centro Internacional de Entrenamiento e Investigaciones Médicas

  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)