Hantavirus InfectionsNCT00533767
Hantavirus Transmission in Households in Chile
An observational study of Hantavirus Infections, run by University of New Mexico at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hantavirus Infections
- How many people
- 197 participants
- Where
- 1 siteChile
- Study dates
- Jul 2007to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 76 index cases with hantavirus cardiopulmonary syndrome and their close household contacts
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Follow Up of Household Contacts and Hantavirus Transmission Study Among Index and Additional Cases in Chile
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.
Read the detailed description
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 patients with HCPS and in household contacts that 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; to develop a predictive statistical model where the epidemiological and the virological variables (cultures, ANDV antibodies, PCR, neutralizing antibodies, HSV 1 and 2 antibodies) could be scored and used to predict a new case within a household group; to determine the feasibility of rapid viral diagnostic testing to determine whether virologic results can be obtained sufficiently in advance of the onset of illness to permit more effective triage of patients who are indeed about to develop HCPS; and to determine the sequences of ANDV from index and additional cases to establish the extent of sequence identity from viruses within and outside of family clusters.
The primary endpoints of this study are: to determine the incidence of additional cases of hantavirus (ANDV) among close household contacts of a confirmed index case during a complete incubation period of follow up; evaluate risk activities and demographic factors associated with increased risk of transmission of ANDV between index cases and members of households and their respective index cases; measure risk activities and demographic factors associated with increased risk of acquisition of ANDV from environmental sources by comparing index cases with household contacts that do and do not develop HCPS; and determine the presence of virus and measure of viral RNA in body fluids over time in index cases and in additional cases in household contacts.
The secondary endpoints will be: to determine the most sensitive culture approach for detection of ANDV in body fluids at different stages of infection; identify the best model to predict the occurrence of an additional case within a family group; evaluate nucleotide similarity as ancillary marker to enrich or de-enrich the probability of person to person transmission of AND virus. The duration of this study is expected to be 3 years.
- Conditions
- Hantavirus Infections
- Keywords
- Hantavirus cardiopulmonary syndrome, Andes virus, Chile
- Medical subject headings
- Hantavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the secondary attack rate among close household contacts of index cases with hantavirus cardiopulmonary syndrome in Chile
Measured: 35 days
Secondary outcomes (1)
Determine the quantity of hantavirus in bodily fluids in persons with hantavirus infection
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: This is not a clinical trial and was inadvertently added to the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hantavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Mertz, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533767
- Sponsor's protocol ID
- 07-0013
- Status last verified
- Jan 2024
- First submitted
- 20 Sep 2007
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow Up of Household Contacts and Hantavirus Transmission Study Among Index and Additional Cases in Chile
- ClinicalTrials.gov ID
- NCT00533767
- Acronym / sponsor ID
- 07-0013
- Conditions
- Hantavirus Infections
- Keywords
- Hantavirus cardiopulmonary syndrome, Andes virus, Chile
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is not a clinical trial and was inadvertently added to the system.
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2007 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 patients with HCPS and in household contacts that 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; to develop a predictive statistical model where the epidemiological and the virological variables (cultures, ANDV antibodies, PCR, neutralizing antibodies, HSV 1 and 2 antibodies) could be scored and used to predict a new case within a household group; to determine the feasibility of rapid viral diagnostic testing to determine whether virologic results can be obtained sufficiently in advance of the onset of illness to permit more effective triage of patients who are indeed about to develop HCPS; and to determine the sequences of ANDV from index and additional cases to establish the extent of sequence identity from viruses within and outside of family clusters.
The primary endpoints of this study are: to determine the incidence of additional cases of hantavirus (ANDV) among close household contacts of a confirmed index case during a complete incubation period of follow up; evaluate risk activities and demographic factors associated with increased risk of transmission of ANDV between index cases and members of households and their respective index cases; measure risk activities and demographic factors associated with increased risk of acquisition of ANDV from environmental sources by comparing index cases with household contacts that do and do not develop HCPS; and determine the presence of virus and measure of viral RNA in body fluids over time in index cases and in additional cases in household contacts.
The secondary endpoints will be: to determine the most sensitive culture approach for detection of ANDV in body fluids at different stages of infection; identify the best model to predict the occurrence of an additional case within a family group; evaluate nucleotide similarity as ancillary marker to enrich or de-enrich the probability of person to person transmission of AND virus. The duration of this study is expected to be 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 76 index cases with hantavirus cardiopulmonary syndrome and their close household contacts
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate the secondary attack rate among close household contacts of index cases with hantavirus cardiopulmonary syndrome in Chile
Time frame: 35 days
1 secondary outcome
Determine the quantity of hantavirus in bodily fluids in persons with hantavirus infection
Time frame: 35 days
Results and safety
The study was stopped early (reason given: This is not a clinical trial and was inadvertently added to the system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Mertz, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hantavirus Infections, run by University of New Mexico at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This is not a clinical trial and was inadvertently added to the system.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the secondary attack rate among close household contacts of index cases with hantavirus cardiopulmonary syndrome in Chile (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.