Clinical Trial: Hantavirus Transmission in Households in Chile

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective Follow Up of Household Contacts and Hantavirus Transmission Study Among Index and Additional Cases in Chile

Brief Summary: This study is designed to evaluate the transmission of hantavirus in Chile. It is an observational study that will look at close household contacts of people who have been diagnosed with hantavirus infections that result in a serious illness to see how frequently they become infected. Subjects who enroll in the study will donate samples of body fluids (e.g., blood, saliva, stool, urine, respiratory and vaginal secretions) to allow the researchers to see if hantavirus is present in those fluids and if so, how much. Subjects will also be interviewed to identify household conditions that may be associated with transmission. Up to 76 index cases (people who are first diagnosed with hantavirus cadiopulmonary illness) and up to 140 of their close contacts will be enrolled. Subjects will be followed for about 6 weeks.

Detailed Summary:

Hantavirus cardiopulmonary syndrome (HCPS) has a case fatality rate of 40-50 percent. Andes virus (ANDV) is the primary pathogen in Chile and Argentina. This is a prospective observational study to access the incidence of and risk factors associated with transmission of HCPS to close household contacts from HCPS index cases including examination of the shedding of virus in various body fluids as a factor in transmissibility. The study will enroll 76 cardiopulmonary syndrome HCPS index cases and 140 of their close household contacts, age 2 and older, at risk for contracting HCPS.

The index cases will participate for the initial visit; the household contact participants will be followed for 35 days. The primary objectives of this study are: to estimate the secondary attack rate of hantavirus infection among close household contacts of an HCPS case after one incubation period of follow up; to use personal interviews and questionnaires to assess and compare risk activities and demographic factors in close household contacts who develop HCPS with those contacts who do not identify specific high-risk activities such as exposure to saliva or respiratory secretions; to use personal interviews and questionnaires to assess and compare risk activities and demographic factors in index cases (the first case in the household) versus household contacts who do not develop HCPS; and to determine the prevalence of hantavirus in various body fluids in index patients with HCPS and in household contacts who acquire infection and consequently determine any association of presence of virus in a body fluid with phase of infection.

Both infectious virus (culture) and viral genomic RNA (quantitative RT-PCR) will be measured. The secondary objectives of this study will be: to determine the quantity of hantavirus in various body fluids in index patie
Sponsor: University of New Mexico

Current Primary Outcome: Estimate the secondary attack rate among close household contacts of index cases with hantavirus cardiopulmonary syndrome in Chile [ Time Frame: 35 days ]

Original Primary Outcome:

Current Secondary Outcome: Determine the quantity of hantavirus in bodily fluids in persons with hantavirus infection [ Time Frame: 35 days ]

Original Secondary Outcome:

Information By: University of New Mexico

Dates:
Date Received: September 20, 2007
Date Started: July 2007
Date Completion:
Last Updated: December 5, 2014
Last Verified: December 2014