Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 5:59 PM
Study NCT ID:
NCT00446628
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2007-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project to Investigate Ways to Reduce the Spread of Influenza in Schools and Households With Children
Sponsor:
Kiren Mitruka
Organization:
Study Overview
Official Title:
Pittsburgh Influenza Prevention Project
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIPP
Brief 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.
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
1. 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
2. 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.
3. 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.
4. Measure the effectiveness of NPIs in reducing secondary spread of ILI within classrooms of participating schools.
5. Assess adoption of NPI behaviors and activities in classrooms of intervention schools.
Secondary: Home-Based
6. Measure the effectiveness of NPIs in reducing secondary cases of ILI within families of enrolled school children with influenza.
7. Assess adherence of families of enrolled school children with influenza to isolation-related NPI behaviors and activities.
Tertiary
8. Measure correlation between rapid flu testing and PCR testing for influenza.
9. Collect and archive influenza specimens for future molecular epidemiological studies.
10. Contribute a sample of influenza-positive specimens to the CDC for national influenza surveillance purposes.
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
1. 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
2. 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.
3. 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.
4. Measure the effectiveness of NPIs in reducing secondary spread of ILI within classrooms of participating schools.
5. Assess adoption of NPI behaviors and activities in classrooms of intervention schools.
Secondary: Home-Based
6. Measure the effectiveness of NPIs in reducing secondary cases of ILI within families of enrolled school children with influenza.
7. Assess adherence of families of enrolled school children with influenza to isolation-related NPI behaviors and activities.
Tertiary
8. Measure correlation between rapid flu testing and PCR testing for influenza.
9. Collect and archive influenza specimens for future molecular epidemiological studies.
10. Contribute a sample of influenza-positive specimens to the CDC for national influenza surveillance purposes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDC-U01 CI000435-01 | OTHER_GRANT | CDC | View |