InfluenzaPIPPNCT00446628
Project to Investigate Ways to Reduce the Spread of Influenza in Schools and Households With Children
A study testing behaviors reducing spread of influenza in people with Influenza, run by Kiren Mitruka at 1 site in United States.
Trial summary
The purpose of this study is to understand the spread of influenza (flu) in schools and households with elementary (K-5) school children, and develop ways to reduce the flu using non-pharmaceutical means. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- behaviors reducing spread of influenza
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,360 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Sep 2009
- Phase
- Interventional
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students in grades K-8 with a current influenza-like illness (ILI) during flu season.ILI defined as an oral or aural temperature > 100 °F AND either new onset cough or sore throat.Flu season is defined as December, 2006 through March/April, 2007.
- Parental consent and student assent.
- Shares living space with K-8 child who has current influenza infection.
- Parental consent and child assent in the case of minors.
- Individual consent if over the age of 18.
- Will continue in the study even if student with confirmed influenza withdraws from the study.
Who cannot join
- The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation.
- The participant is unable to tolerate a swab or capillary finger stick.
- There is a delay in notification or testing such that symptoms have resolved.
- The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation.
- The participant is younger than 6 months.
- The participant is unable to tolerate a swab or capillary finger stick.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Pittsburgh Influenza Prevention Project
The purpose of this study is to understand the spread of influenza (flu) in schools and households with elementary (K-5) school children, and develop ways to reduce the flu using non-pharmaceutical means.
Read the detailed description
Pandemic influenza threatens to cause substantial disability, death, and societal disruption and to overwhelm health care systems in the United States and around the world. Because effective vaccines may not be available during the initial months of a pandemic, and because anti-viral medication is both largely ineffective and in short supply, non-pharmacological personal protection and behavioral changes may be the only means to combat the epidemic. In our computational modeling work (through the Models of Infectious Disease Agent Study network), we have shown the potential value of multiple targeted and layered non-pharmacological interventions in blunting the peak impact and slowing of a pandemic (Nature, in press).
Phase 1 of the project will be a pilot study in two elementary schools in the City of Pittsburgh. The project has already obtained agreement to collaborate from the Pittsburgh Public School System and we have assembled a multi-disciplinary team of epidemiologists, systems analysts, modelers, community and minority health workers, and virologists to implement the project. Phase one was in 2 schools.
Phase 2 will be similar to Phase 1 with the addition of additional schools and application of a "hygiene" intervention to selected schools and families. Phase 2 is in 10 schools with 3800 students.
Specific aims (year 02):
Primary
- Measure the effectiveness of non-pharmaceutical interventions (NPIs) in reducing influenza rates among enrolled students in the intervention and control schools when influenza is known to be circulating in the community. [Note: Enrolled, for purposes of PIPP, will indicate students who present with ILI, consent to participate, and are tested for influenza during the flu season.] Secondary: School-Based
- Measure number of absentees and determine the reason for absence by using a school based absentee illness surveillance system prior to and through the end of influenza season.
- Measure the effectiveness of NPIs in reducing absenteeism from all causes, including illness/URI, illness/ILI, illness/other, and illness/GI through the end of influenza season.
- Measure the effectiveness of NPIs in reducing secondary spread of ILI within classrooms of participating schools.
- Assess adoption of NPI behaviors and activities in classrooms of intervention schools. Secondary: Home-Based
- Measure the effectiveness of NPIs in reducing secondary cases of ILI within families of enrolled school children with influenza.
- Assess adherence of families of enrolled school children with influenza to isolation-related NPI behaviors and activities. Tertiary
- Measure correlation between rapid flu testing and PCR testing for influenza.
- Collect and archive influenza specimens for future molecular epidemiological studies.
- Contribute a sample of influenza-positive specimens to the CDC for national influenza surveillance purposes.
- Conditions
- Influenza
- Being tested
- behaviors reducing spread of influenza
- Keywords
- Non-pharmaceutical, influenza, pandemic
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behaviors reducing spread of influenzaBehavioural
Non-pharmaceutical interventions for flu prevention
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Five elementary school received intervention consistin of training in hand and respiratory hygiene, and access to hand sanitizer Receives: Behavioral: behaviors reducing spread of influenza |
| control | No intervention | Five elementary school received no training or hand sanitizer. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiren Mitruka
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Kiren Mitruka, Centers for Disease Control and Prevention
- Investigators
- Donald S Burke, MD, Principal investigator, University of PittsburghSam Stebbins, MD, MPH, Principal investigator, University of Pittsburgh School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446628
- Sponsor's protocol ID
- CDC-NCPDCID-CC-0612047
- Other IDs
- CDC-U01 CI000435-01
- Acronym
- PIPP
- Status last verified
- Jan 2016
- First submitted
- 12 Mar 2007
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pittsburgh Influenza Prevention Project
- ClinicalTrials.gov ID
- NCT00446628
- Acronym / sponsor ID
- PIPP / CDC-NCPDCID-CC-0612047
- Conditions
- Influenza
- Keywords
- Non-pharmaceutical, influenza, pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,360 participants (actual)
- Lead sponsor
- Kiren MitrukaUS federal agency
- Study start
- Jan 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Mar 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.
The purpose of this study is to understand the spread of influenza (flu) in schools and households with elementary (K-5) school children, and develop ways to reduce the flu using non-pharmaceutical means.
Detailed description
Pandemic influenza threatens to cause substantial disability, death, and societal disruption and to overwhelm health care systems in the United States and around the world. Because effective vaccines may not be available during the initial months of a pandemic, and because anti-viral medication is both largely ineffective and in short supply, non-pharmacological personal protection and behavioral changes may be the only means to combat the epidemic. In our computational modeling work (through the Models of Infectious Disease Agent Study network), we have shown the potential value of multiple targeted and layered non-pharmacological interventions in blunting the peak impact and slowing of a pandemic (Nature, in press).
Phase 1 of the project will be a pilot study in two elementary schools in the City of Pittsburgh. The project has already obtained agreement to collaborate from the Pittsburgh Public School System and we have assembled a multi-disciplinary team of epidemiologists, systems analysts, modelers, community and minority health workers, and virologists to implement the project. Phase one was in 2 schools.
Phase 2 will be similar to Phase 1 with the addition of additional schools and application of a "hygiene" intervention to selected schools and families. Phase 2 is in 10 schools with 3800 students.
Specific aims (year 02):
Primary
- Measure the effectiveness of non-pharmaceutical interventions (NPIs) in reducing influenza rates among enrolled students in the intervention and control schools when influenza is known to be circulating in the community. [Note: Enrolled, for purposes of PIPP, will indicate students who present with ILI, consent to participate, and are tested for influenza during the flu season.] Secondary: School-Based
- Measure number of absentees and determine the reason for absence by using a school based absentee illness surveillance system prior to and through the end of influenza season.
- Measure the effectiveness of NPIs in reducing absenteeism from all causes, including illness/URI, illness/ILI, illness/other, and illness/GI through the end of influenza season.
- Measure the effectiveness of NPIs in reducing secondary spread of ILI within classrooms of participating schools.
- Assess adoption of NPI behaviors and activities in classrooms of intervention schools. Secondary: Home-Based
- Measure the effectiveness of NPIs in reducing secondary cases of ILI within families of enrolled school children with influenza.
- Assess adherence of families of enrolled school children with influenza to isolation-related NPI behaviors and activities. Tertiary
- Measure correlation between rapid flu testing and PCR testing for influenza.
- Collect and archive influenza specimens for future molecular epidemiological studies.
- Contribute a sample of influenza-positive specimens to the CDC for national influenza surveillance purposes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: behaviors reducing spread of influenzaFive elementary school received intervention consistin of training in hand and respiratory hygiene, and access to hand sanitizer |
| control | No intervention | –Five elementary school received no training or hand sanitizer. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Students in grades K-8 with a current influenza-like illness (ILI) during flu season.ILI defined as an oral or aural temperature > 100 °F AND either new onset cough or sore throat.Flu season is defined as December, 2006 through March/April, 2007.
- Parental consent and student assent.
- Shares living space with K-8 child who has current influenza infection.
- Parental consent and child assent in the case of minors.
- Individual consent if over the age of 18.
Key exclusion criteria (6 listed)
- The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation.
- The participant is unable to tolerate a swab or capillary finger stick.
- There is a delay in notification or testing such that symptoms have resolved.
- The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation.
- The participant is younger than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behaviors reducing spread of influenzaNon-pharmaceutical interventions for flu prevention | Behavioural | intervention |
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 27 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Donald S Burke, MD principal investigator
University of Pittsburgh
Sam Stebbins, MD, MPH principal investigator
University of Pittsburgh School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behaviors reducing spread of influenza in people with Influenza, run by Kiren Mitruka at 1 site in United States.
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 6 inclusion and 6 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 27 Jan 2016. 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 United States. 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 27 Jan 2016.