Staphylococcus AureusNCT01385514
Staphylococcus Aureus Skin and Soft Tissue Infections
An observational study of Staphylococcus Aureus, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate strategies to prevent Staphylococcus aureus skin and soft tissue infections in soldiers during infantry training. This study will be conducted on three different bases among groups of male recruits to IDF training base. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus
- How many people
- 1,050 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Dec 2013
- Phase
- Observational
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: the population of the study will be selected from infantry training bases in the IDF
Who may be able to join
- new recruit for a combat training unit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Strategies to Prevent Staphylococcus Aureus Skin and Soft Tissue Infections in Soldiers During Infantry Training
The purpose of this study is to evaluate strategies to prevent Staphylococcus aureus skin and soft tissue infections in soldiers during infantry training.
This study will be conducted on three different bases among groups of male recruits to IDF training base. They will provide nasal swabs to detect Staphylococcus aureus carriage in two time points: 1. before mixing and training in confined settings, reflecting carriage acquired before entering 2. After 14-30 days. All soldiers will be under surveillance for skin infection until the end of the training program.
- Conditions
- Staphylococcus Aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| company A-Training Base No.1 | Not described | |
| company A-Training Base No.2 | Not described | |
| company A-Training Base No.3 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJul 2011
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Hartal, MD, Principal investigator, International Diabetes Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385514
- Sponsor's protocol ID
- 1042-2011
- Status last verified
- Mar 2012
- First submitted
- 28 Jun 2011
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Strategies to Prevent Staphylococcus Aureus Skin and Soft Tissue Infections in Soldiers During Infantry Training
- ClinicalTrials.gov ID
- NCT01385514
- Acronym / sponsor ID
- 1042-2011
- Conditions
- Staphylococcus Aureus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Jul 2011
- Study completion
- Dec 2013 (estimated)
- First posted
- 30 Jun 2011 (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 evaluate strategies to prevent Staphylococcus aureus skin and soft tissue infections in soldiers during infantry training.
This study will be conducted on three different bases among groups of male recruits to IDF training base. They will provide nasal swabs to detect Staphylococcus aureus carriage in two time points: 1. before mixing and training in confined settings, reflecting carriage acquired before entering 2. After 14-30 days. All soldiers will be under surveillance for skin infection until the end of the training program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| company A-Training Base No.1 | – | – |
| company A-Training Base No.2 | – | – |
| company A-Training Base No.3 | – | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- the population of the study will be selected from infantry training bases in the IDF
Key inclusion criteria (1 listed)
- new recruit for a combat training unit
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
Michael Hartal, MD principal investigator
International Diabetes Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus, run by Medical Corps, Israel Defense Force at 1 site in 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 1 inclusion and 0 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 23 Mar 2012. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Hartal, MD (+972-3-7374137, Mhuerta2@gmail.com), or a site near the patient. 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 23 Mar 2012.