Hantavirus Transmission in Households in Chile

NCT00533767 | Terminated

• 1 other identifier: 07-0013
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Hantavirus Infections

Keywords

Hantavirus cardiopulmonary syndrome, Andes virus, Chile

Outcome Measures

Primary Outcomes (1)

• Estimate the secondary attack rate among close household contacts of index cases with hantavirus cardiopulmonary syndrome in Chile

  35 days

Secondary Outcomes (1)

• Determine the quantity of hantavirus in bodily fluids in persons with hantavirus infection

  35 days

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

76 index cases with hantavirus cardiopulmonary syndrome and their close household contacts

You may qualify if:

• Index Cases:
• Confirmed diagnosis, positive hantavirus IgM assay or detection of hantavirus in plasma or serum by RT-PCR.
• Signed informed consent form.
• Less than 96 hours have transpired since the diagnosis was confirmed.
• Household Contact
• Any person, 2 years of age or older, who has been in close contact with the index case at any point from 30 days before to 7 days after the onset of symptoms in the index case.
• Close contact must include: sexual contact and/or deep kissing and/or slept in same bed and/or provided direct care to index case.

You may not qualify if:

• Index Cases
• Index case does not have or agree to give the names of his/her close contacts.
• Not a suitable candidate in the opinion of the investigator.
• Household Contact
• Confirmed current or previous infection with Andes virus.
• Younger than 2 years of age.
• Unavailable for follow up or not a suitable candidate in the opinion of the investigator.

Sponsors & Collaborators

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

Study Sites (1)

Universidad Catolica de Chile

Santiago, Chile

Location

MeSH Terms

Conditions

Hantavirus Infections

Condition Hierarchy (Ancestors)

Bunyaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Gregory Mertz, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

CL (1)