Respiratory Tract InfectionsNCT00517660
Source Profiling of Biohazardous Aerosols in Hospitals
An observational study of Respiratory Tract Infections, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
To characterise the physical parameters (number concentration, size distribution and their trajectories) of aerosols (droplets) generated in high risk procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2006to Jun 2006
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 60 from each groups. Healthy subjects - recruited from voluntary basis. LRTI - recruited from patient wards with consent. URTI - recruited from out-patient clinic with consent.
Who may be able to join
- Adult patients (>18 years old) that can give valid consent
- URTI: with symptoms such as coryza, sore throat, nasal discharge, cough and sputum +/- fever. Amongst these, cough should be a major complaint.
- LRTI (CAP): acute lower respiratory illness of no other known cause which is usually associated with fever, symptoms and signs of the chest and abnormalities on the CXR. (BTS 1993).
Who cannot join
- Pneumonia developed at or after 48 hours, or history of hospital admissions within 1 month of the present admission (to exclude hospital-acquired infections)
- Patients who are unable to cooperate with the study protocols (such as mentally confused, dementia) or are physically unable to sit or stand independently to carry out the tests optimally.
- Patients with TOCC associations with infections such Avian Flu or SARS (travel to endemic areas, at-risk occupations, close contacts with index cases, especially with compatible clinical features) or NPA revealed positivity of influenza A/B
- Patients who are clinically or haemodynamically unstable, such as the need for inotropes, oxygen supplement of >2L/min, any types of shock, etc.
- Underlying diseases that might affect the coughing effort (such as musculoskeletal diseases, or severe kyphoscoliosis)
Trial locations and contacts
1 site in 1 country.
About this study
To characterise the physical parameters (number concentration, size distribution and their trajectories) of aerosols (droplets) generated in high risk procedures.
- Conditions
- Respiratory Tract Infections
- Keywords
- Healthy subjects, Lower Respiratory Tract Infections, Upper Respiratory Tract Infections
- Medical subject headings
- Respiratory Tract Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startMar 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Hong Kong University of Science and Technology
- Investigators
- Ming Fang, Prof, Principal investigator, Institute for the Environment, The Hong Kong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517660
- Sponsor's protocol ID
- KC/KE-04-0071/ER-1
- Other IDs
- HARECCTR0500055
- Status last verified
- Aug 2013
- First submitted
- 15 Aug 2007
- Last updated
- 22 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Source Profiling of Biohazardous Aerosols in Hospitals
- ClinicalTrials.gov ID
- NCT00517660
- Acronym / sponsor ID
- KC/KE-04-0071/ER-1
- Conditions
- Respiratory Tract Infections
- Keywords
- Healthy subjects, Lower Respiratory Tract Infections, Upper Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Hong Kong University of Science and Technology
- Study start
- Mar 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 17 Aug 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.
To characterise the physical parameters (number concentration, size distribution and their trajectories) of aerosols (droplets) generated in high risk procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 60 from each groups. Healthy subjects - recruited from voluntary basis. LRTI - recruited from patient wards with consent. URTI - recruited from out-patient clinic with consent.
Key inclusion criteria (3 listed)
- Adult patients (>18 years old) that can give valid consent
- URTI: with symptoms such as coryza, sore throat, nasal discharge, cough and sputum +/- fever. Amongst these, cough should be a major complaint.
- LRTI (CAP): acute lower respiratory illness of no other known cause which is usually associated with fever, symptoms and signs of the chest and abnormalities on the CXR. (BTS 1993).
Key exclusion criteria (5 listed)
- Pneumonia developed at or after 48 hours, or history of hospital admissions within 1 month of the present admission (to exclude hospital-acquired infections)
- Patients who are unable to cooperate with the study protocols (such as mentally confused, dementia) or are physically unable to sit or stand independently to carry out the tests optimally.
- Patients with TOCC associations with infections such Avian Flu or SARS (travel to endemic areas, at-risk occupations, close contacts with index cases, especially with compatible clinical features) or NPA revealed positivity of influenza A/B
- Patients who are clinically or haemodynamically unstable, such as the need for inotropes, oxygen supplement of >2L/min, any types of shock, etc.
- Underlying diseases that might affect the coughing effort (such as musculoskeletal diseases, or severe kyphoscoliosis)
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
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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.
Ming Fang, Prof principal investigator
Institute for the Environment, The Hong Kong University of Science and Technology
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 Respiratory Tract Infections, run by Hospital Authority, Hong Kong at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Aug 2013. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 22 Aug 2013.