Transmission ConditionNCT00173121
Environmental Enterovirus Monitoring
An observational study of Transmission Condition, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
From last decades, because of lacking the powerful quantitative methods, such as real-time qPCR, there is no environmental monitoring data about enterovirus transmission. If the major transmission routes and risk factor are still not clear, it will be very hard for making the prevention and control strategies. Read more about this study
- Who is it for?
- Ages 1 week to 18 years
- Conditions the study is for
- Transmission Condition
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2005to Jun 2005
- 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 1 week to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- any case of enterovirus infection
Who cannot join
- not enterovirus infection cases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hsopital
Taipei, Taipei, 100
Luan-Yin Chang, MD, PhD, ly7077@tpts6.seed.net.tw
Luan-Yin Chang, MD, PhD
About this study
From last decades, because of lacking the powerful quantitative methods, such as real-time qPCR, there is no environmental monitoring data about enterovirus transmission. If the major transmission routes and risk factor are still not clear, it will be very hard for making the prevention and control strategies. Today, the most popular prevention suggestion for children is keeping them away from crowded public places during the peak contagious season, because enteroviruses are easily transmitted through aerosols over a distance of meters, and even between separated rooms (Chang et al., 2004). However, adults may as easily be infected, but don』t have any disease symptoms or carry the virus home. Another recommendation is washing hands to avoid contact of hands or anything else with the mouth and nose, as it is through contact of viruses with the mucosal membranes in the mouth and nasal passages that infection occurs. However, these actions did not be great helpful for preventing enterovirus infection and spread. Understanding and disrupting the major transmission pass way of enterovirus could be more effective than just keeping personal hygiene. Therefore, an applicable environmental monitoring program is needed for understanding the transmission routes and risk factor of enterovirus infection. In this study, we will monitor enteroviruses in hospital, household and kindergarten. For the environmental monitoring of enteroviruses, we will apply traditional plaque assay, real-time quantitative PCR and combine with questionnaire-based interviews to understand the infectious types and concentration of enterovirus from indoor air, surface and water for recognizing the transmission routes of enterovirus and the relationships between virus concentration and the symptoms of the cases.
Read the detailed description
Environmental Monitoring Program for Enterovirus (1) Case Collection. The studies cases include patients who were suspected of having enterovirus illnesses, such as HFMD and herpangina. Institutional review board approval was obtained from the Hospital for this study and informed consent was obtained from all patients or their parents. (2) Questionnaire. questionnaire based interviews were used to collect information about the family members, including demographic data, the number of bedrooms in the house, amount of contact time with the patient, presence and pattern of current or recent signs and symptoms. (3) Patient and culture samples. Laboratory evidence of enterovirus infection was defined as the isolation of enterovirus from a throat , and rectal swab sample. (4) Environmental Sampling. (a) Air sampling. For the filter/real-time qPCR assay, the air in each ward was filtered through a 37-mm-diameter Nuclepore filter (Costar, Cambridge, MA), which is a track-etched polycarbonate filter consisting of a polycarbonate membrane with straight-through pores of uniform size (0.4 μm). The filters were supported by cellulose pads and loaded into open-face three-piece plastic cassettes. The pump and filter apparatus were placed within 1 m from the patient's bed on an adjacent nightstand. (b) Surface sampling Regarding surface sampling, surfaces of environment and equipment were sampled with moistened sterile cotton swabs.
- Conditions
- Transmission Condition
- Keywords
- enterovirus, environment, aerosol, air
- Medical subject headings
- Enterovirus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transmission ConditionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Luan-Yin Chang Chang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173121
- Sponsor's protocol ID
- 9461700414
- Status last verified
- Apr 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Enterovirus Monitoring
- ClinicalTrials.gov ID
- NCT00173121
- Acronym / sponsor ID
- 9461700414
- Conditions
- Transmission Condition
- Keywords
- enterovirus, environment, aerosol, air
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Jun 2005
- First posted
- 15 Sep 2005 (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.
From last decades, because of lacking the powerful quantitative methods, such as real-time qPCR, there is no environmental monitoring data about enterovirus transmission. If the major transmission routes and risk factor are still not clear, it will be very hard for making the prevention and control strategies. Today, the most popular prevention suggestion for children is keeping them away from crowded public places during the peak contagious season, because enteroviruses are easily transmitted through aerosols over a distance of meters, and even between separated rooms (Chang et al., 2004). However, adults may as easily be infected, but don』t have any disease symptoms or carry the virus home. Another recommendation is washing hands to avoid contact of hands or anything else with the mouth and nose, as it is through contact of viruses with the mucosal membranes in the mouth and nasal passages that infection occurs. However, these actions did not be great helpful for preventing enterovirus infection and spread. Understanding and disrupting the major transmission pass way of enterovirus could be more effective than just keeping personal hygiene. Therefore, an applicable environmental monitoring program is needed for understanding the transmission routes and risk factor of enterovirus infection. In this study, we will monitor enteroviruses in hospital, household and kindergarten. For the environmental monitoring of enteroviruses, we will apply traditional plaque assay, real-time quantitative PCR and combine with questionnaire-based interviews to understand the infectious types and concentration of enterovirus from indoor air, surface and water for recognizing the transmission routes of enterovirus and the relationships between virus concentration and the symptoms of the cases.
Detailed description
Environmental Monitoring Program for Enterovirus (1) Case Collection. The studies cases include patients who were suspected of having enterovirus illnesses, such as HFMD and herpangina. Institutional review board approval was obtained from the Hospital for this study and informed consent was obtained from all patients or their parents. (2) Questionnaire. questionnaire based interviews were used to collect information about the family members, including demographic data, the number of bedrooms in the house, amount of contact time with the patient, presence and pattern of current or recent signs and symptoms. (3) Patient and culture samples. Laboratory evidence of enterovirus infection was defined as the isolation of enterovirus from a throat , and rectal swab sample. (4) Environmental Sampling. (a) Air sampling. For the filter/real-time qPCR assay, the air in each ward was filtered through a 37-mm-diameter Nuclepore filter (Costar, Cambridge, MA), which is a track-etched polycarbonate filter consisting of a polycarbonate membrane with straight-through pores of uniform size (0.4 μm). The filters were supported by cellulose pads and loaded into open-face three-piece plastic cassettes. The pump and filter apparatus were placed within 1 m from the patient's bed on an adjacent nightstand. (b) Surface sampling Regarding surface sampling, surfaces of environment and equipment were sampled with moistened sterile cotton swabs.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 1 week to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- any case of enterovirus infection
Key exclusion criteria (1 listed)
- not enterovirus infection cases
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Luan-Yin Chang Chang, MD, PhD principal investigator
National Taiwan University Hospital
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 Transmission Condition, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luan-Yin Chang, MD (886-2-23123456 ext. 3245, ly7077@tpts6.seed.net.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Sep 2005.