InfluenzaNCT00410176
A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family
A study testing sanitation and personal hygiene in people with Influenza, run by Ministry of Health, Israel.
Trial 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 family.This will be achieved by conducting a randomized, controlled, unblinded, clinical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- What is being tested?
- sanitation and personal hygiene
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to not given
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Family members of an index case with influenza-like illness (ILI) during the first two days of his illness.
- No limitations will be given regarding the number of family members.
Who cannot join
- Presence of another household member with ILI during the previous two weeks.
Trial locations and contacts
No sites are listed yet.
About this study
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 family.This 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%.
- Conditions
- Influenza
- Being tested
- sanitation and personal hygiene
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sanitation and personal hygieneBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary infection of influenza within the family
Secondary outcomes (1)
compliance of non-pharmaceutical interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startJan 2007
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
- 400 participants
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Israel
- Sponsor type
- Other government
- Investigators
- Manfred S Green, PhD, M.D, Principal investigator, ICDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410176
- Sponsor's protocol ID
- 4335CTIL
- Status last verified
- Dec 2006
- First submitted
- 11 Dec 2006
- Last updated
- 12 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family
- ClinicalTrials.gov ID
- NCT00410176
- Acronym / sponsor ID
- 4335CTIL
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- Ministry of Health, IsraelOther government
- Study start
- Jan 2007
- First posted
- 12 Dec 2006 (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 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 family.This 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%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Family members of an index case with influenza-like illness (ILI) during the first two days of his illness.
- No limitations will be given regarding the number of family members.
Key exclusion criteria (1 listed)
- Presence of another household member with ILI during the previous two weeks.
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 |
|---|---|---|
| sanitation and personal hygiene | Behavioural | – |
Primary outcome
secondary infection of influenza within the family
1 secondary outcome
compliance of non-pharmaceutical interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2006.
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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.
Manfred S Green, PhD, M.D principal investigator
ICDC
Questions about this trial
What is this clinical trial studying?
A study testing sanitation and personal hygiene in people with Influenza, run by Ministry of Health, Israel.
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 2 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 12 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
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 Manfred S Green, PhD, M.D (972-3-7371500 ext. 203, m.green@icdc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secondary infection of influenza within the family. It is what the study was designed to measure, not a finding.
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 12 Dec 2006.