InfectionsVirusFightNCT01887730
Hand Hygiene Intervention Study in Finnish Garrison
A study testing Hand washing with soap and water and Hand cleaning with alcohol-containing hand rub in people with Infections, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
In this study the investigators aim to elucidate the possibility to reduce occurrence of infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators will study occurrence and transmission of infections. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Hand washing with soap and water and Hand cleaning with alcohol-containing hand rub
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,120 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2012to Dec 2020
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- willingness to attend to the study
Who cannot join
- skin diseases which prevent using hand disinfectants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Intensified Hand Hygiene Decrease Morbidity and Lost Service Days in a Garrison
In this study the investigators aim to elucidate the possibility to reduce occurrence of infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators will study occurrence and transmission of infections. In addition, the investigators will find out the causative agents of infections in a garrison with virological analyses of naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due to infectious diseases will be evaluated with a cost analysis study.
- Conditions
- Infections
- Being tested
- Hand washing with soap and water, Hand cleaning with alcohol-containing hand rub, Control
- Keywords
- Hand Hygiene, Communicable Diseases, Prevention
- Medical subject headings
- Infections, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand washing with soap and waterBehavioural
Can infections be prevented by hand washing with soap and water
Hand cleaning with alcohol-containing hand rubBehavioural
Can infections be prevented by hand cleaning with alcohol-containing hand rub. Effect of intervention is assessed by following occurrence of infections
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| arm 2 | Active comparator | Hand washing with soap and water according to instructions. The effect of intervention is assessed by following occurrence of infections. Receives: Behavioral: Hand washing with soap and water |
| arm 0 | Placebo comparator | No specific advice on hand hygiene. The effect of intervention is assessed by following occurrence of infections. Receives: Behavioral: Control |
| Arm 3 | Active comparator | Hand cleaning with alcohol-containing hand rub Receives: Behavioral: Hand cleaning with alcohol-containing hand rub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infection episodes during basic training period. The periods when a person has been in duty in spite of the infection will be included.
Measured: 8 weeks
Secondary outcomes (2)
Length of distinct infection episodes due to infectious disease
Measured: 8 weeks
Length of distinct absence episodes due to infectious disease.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionDec 2020 (estimated)
Why it stopped: Organizational changes and lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Finnish Defense Forces
- Responsible party
- Sponsor
- Investigators
- Carita Savolainen-Kopra, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887730
- Sponsor's protocol ID
- THL/81/6.05.00/2012
- Acronym
- VirusFight
- Status last verified
- Aug 2018
- First submitted
- 19 Jun 2013
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Intensified Hand Hygiene Decrease Morbidity and Lost Service Days in a Garrison
- ClinicalTrials.gov ID
- NCT01887730
- Acronym / sponsor ID
- VirusFight / THL/81/6.05.00/2012
- Conditions
- Infections
- Keywords
- Hand Hygiene, Communicable Diseases, Prevention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Organizational changes and lack of resources
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Finnish Defense Forces
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Jun 2013 (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.
In this study the investigators aim to elucidate the possibility to reduce occurrence of infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators will study occurrence and transmission of infections. In addition, the investigators will find out the causative agents of infections in a garrison with virological analyses of naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due to infectious diseases will be evaluated with a cost analysis study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm 2 | Active comparator | Behavioral: Hand washing with soap and waterHand washing with soap and water according to instructions. The effect of intervention is assessed by following occurrence of infections. |
| arm 0 | Placebo comparator | Behavioral: ControlNo specific advice on hand hygiene. The effect of intervention is assessed by following occurrence of infections. |
| Arm 3 | Active comparator | Behavioral: Hand cleaning with alcohol-containing hand rubHand cleaning with alcohol-containing hand rub |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- willingness to attend to the study
Key exclusion criteria (1 listed)
- skin diseases which prevent using hand disinfectants
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 |
|---|---|---|
| Hand washing with soap and waterCan infections be prevented by hand washing with soap and water | Behavioural | arm 2 |
| Hand cleaning with alcohol-containing hand rubCan infections be prevented by hand cleaning with alcohol-containing hand rub. Effect of intervention is assessed by following occurrence of infections | Behavioural | Arm 3 |
| Control | Behavioural | arm 0 |
Primary outcome
Number of infection episodes during basic training period. The periods when a person has been in duty in spite of the infection will be included.
Time frame: 8 weeks
2 secondary outcomes
Length of distinct infection episodes due to infectious disease
Time frame: 8 weeks
Length of distinct absence episodes due to infectious disease.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
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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.
Carita Savolainen-Kopra principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand washing with soap and water and Hand cleaning with alcohol-containing hand rub in people with Infections, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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 1 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: paused, as of the sponsor's last update on 27 Aug 2018. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infection episodes during basic training period. The periods when a person has been in duty in spite of the infection will be included. (time frame: 8 weeks). 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 27 Aug 2018.