Staphylococcus Aureus Skin and Soft Tissue Infections | NCT01385514

Studies
Staphylococcus Aureus Skin and Soft Tissue Infections

NCT01385514

Sponsor

Medical Corps, Israel Defense Force

Status

Unknown status

Last Update Posted

Mar 23, 2012Estimated

Enrollment

1,050Estimated

Phase

Not provided

Conditions

Staphylococcus Aureus

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Not provided

Completion Date

Dec 2013Estimated

First Submitted Date

Jun 28, 2011

First Submission Date that Met QC Criteria

Jun 29, 2011

First Posted Date

Jun 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2012

Last Update Posted Date

Mar 23, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,050Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

new recruit for a combat training unit

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

the population of the study will be selected from infantry training bases in the IDF

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Hartal, MD	Contact	+972-3-7374137		Mhuerta2@gmail.com

Overall Officials

Name	Affiliation	Role
Michael Hartal, MD	International Diabetes Federation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Israeli Defense Forces	Recruiting	Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D013203	Staphylococcal Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
company A-Training Base No.1
company A-Training Base No.2
company A-Training Base No.3