Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410176
Status:
UNKNOWN
Last Update Posted:
2006-12-12
First Post:
2006-12-11
Brief Title:
A Randomized Controlled Unblinded Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family
Sponsor:
Ministry of Health Israel
Organization:
Ministry of Health Israel
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
The proposed study will evaluate whether the use of non-pharmaceutical methods such as surgical masks isolation of patients and personal hygiene are acceptable and effective in preventing the spread of influenza within the familyThis will be achieved by conducting a randomized controlled unblinded clinical trial Family members of an index case with influenza like illness will be randomly allocated to two groups In the intervention group family members will receive comprehensive guidance about sanitation and hygiene as well as surgical masks to wear whenever in close contact 3 feet 1 meter with the index case In addition they will be asked to isolate the index case as much as possible In the control group family members will receive only standard guidance about sanitation and hygiene relevant for reducing the transmission of influenza The primary end-point of the study will be secondary infection of influenza of at least one of the family members in order to asses the efficacy of the interventions In addition the compliance to those interventions will be evaluated
The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will reduce the secondary infection rate among them by 50
The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will reduce the secondary infection rate among them by 50
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None