Staphylococcus AureusNCT00475930
Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates
A study testing 2% chlorhexidine gluconate (CHG) impregnated cloths in people with Staphylococcus Aureus and Community-acquired Infections, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
Outbreaks of skin and soft tissue infections (SSTI) related to community associated Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in military training units. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus, Community-acquired Infections, Staphylococcal Skin Infections
- What is being tested?
- 2% chlorhexidine gluconate (CHG) impregnated cloths
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,563 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2007
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled in US Marine Officer Candidates School
- Age 18-35 years
- Provide documented informed consent and HIPAA authorization
Who cannot join
- Is currently taking oral antibiotics and will continue to take antibiotics during the study (such as antibiotics used to treat acne)
- Has a known or suspected allergy or intolerance to chlorhexidine (Hibistat, Hibiclens)
- Is currently using certain skin products and is uninterested in stopping use of the products during the study
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Officer Candidates School - Marine Corps Base Quantico
Quantico, Virginia, 22134
About this study
Official title: Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates: A Randomized, Double-Blind, Placebo-Controlled Trial
Outbreaks of skin and soft tissue infections (SSTI) related to community associated Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in military training units. Risk factors for MRSA related SSTI such as crowding, poor hygiene and shared equipment are often hard to avoid in a military training environment, often designed to simulate battlefield conditions.
It has recently been demonstrated that military recruits colonized with MRSA may be at increased risk of developing SSTI. Studies in the hospital environment have shown that decolonizing inpatients known to carry MRSA decreases the rates of MRSA related infections in the treated individuals and also in their inpatient unit as a whole.
Read more
The investigators propose a randomized, double blind, placebo controlled trial to:
- Evaluate the effectiveness, feasibility, and safety of chlorhexidine body cloths, self-administered three times weekly, in preventing SSTI among recruits in military training facilities; and
- Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of Staphylococcus aureus colonization among military recruits.
- Being tested
- 2% chlorhexidine gluconate (CHG) impregnated cloths, Comfort Bath cloths (placebo cloths)
- Keywords
- MRSA, Staphylococcus aureus
- Medical subject headings
- Staphylococcal Infections, Community-Acquired Infections, Staphylococcal Skin Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidine gluconate (CHG) impregnated clothsDrug
Also called Sage Products Inc.
self applied three times per week
Comfort Bath cloths (placebo cloths)Drug
Also called Sage Products Inc.
self applied three times weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2% chlorhexidine gluconate impregnated cloths, self applied three times weekly Receives: Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths |
| 2 | Placebo comparator | Comfort Bath cloths, self applied three times weekly Receives: Drug: Comfort Bath cloths (placebo cloths) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of skin and soft tissue infections among platoons enrolled in OCS.
Measured: May - Nov 2007
Secondary outcomes (1)
The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS.
Measured: May- Nov 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Timothy J Whitman, DO, Principal investigator, National Naval Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475930
- Sponsor's protocol ID
- HU87F7
- Status last verified
- Jul 2025
- First submitted
- 18 May 2007
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Whitman TJ, Herlihy RK, Schlett CD, Murray PR, Grandits GA, Ganesan A, Brown M, Mancuso JD, Adams WB, Tribble DR. Chlorhexidine-impregnated cloths to prevent skin and soft-tissue infection in Marine recruits: a cluster-randomized, double-blind, controlled effectiveness trial. Infect Control Hosp Epidemiol. 2010 Dec;31(12):1207-15. doi: 10.1086/657136. Epub 2010 Oct 28.
PubMed 21028984
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00475930
- Acronym / sponsor ID
- HU87F7
- Keywords
- MRSA, Staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,563 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- May 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 21 May 2007 (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.
Outbreaks of skin and soft tissue infections (SSTI) related to community associated Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in military training units. Risk factors for MRSA related SSTI such as crowding, poor hygiene and shared equipment are often hard to avoid in a military training environment, often designed to simulate battlefield conditions.
It has recently been demonstrated that military recruits colonized with MRSA may be at increased risk of developing SSTI. Studies in the hospital environment have shown that decolonizing inpatients known to carry MRSA decreases the rates of MRSA related infections in the treated individuals and also in their inpatient unit as a whole.
The investigators propose a randomized, double blind, placebo controlled trial to:
- Evaluate the effectiveness, feasibility, and safety of chlorhexidine body cloths, self-administered three times weekly, in preventing SSTI among recruits in military training facilities; and
- Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of Staphylococcus aureus colonization among military recruits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths2% chlorhexidine gluconate impregnated cloths, self applied three times weekly |
| 2 | Placebo comparator | Drug: Comfort Bath cloths (placebo cloths)Comfort Bath cloths, self applied three times weekly |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Enrolled in US Marine Officer Candidates School
- Age 18-35 years
- Provide documented informed consent and HIPAA authorization
Key exclusion criteria (4 listed)
- Is currently taking oral antibiotics and will continue to take antibiotics during the study (such as antibiotics used to treat acne)
- Has a known or suspected allergy or intolerance to chlorhexidine (Hibistat, Hibiclens)
- Is currently using certain skin products and is uninterested in stopping use of the products during the study
- Pregnant or breastfeeding
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 |
|---|---|---|
| 2% chlorhexidine gluconate (CHG) impregnated clothsAlso: Sage Products Inc.self applied three times per week | Drug | 1 |
| Comfort Bath cloths (placebo cloths)Also: Sage Products Inc.self applied three times weekly | Drug | 2 |
Primary outcome
The rate of skin and soft tissue infections among platoons enrolled in OCS.
Time frame: May - Nov 2007
1 secondary outcome
The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS.
Time frame: May- Nov 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Derived from this study: PubMed 21028984Whitman TJ, Herlihy RK, Schlett CD, Murray PR, Grandits GA, Ganesan A, Brown M, Mancuso JD, Adams WB, Tribble DR. Chlorhexidine-impregnated cloths to prevent skin and soft-tissue infection in Marine recruits: a cluster-randomized, double-blind, controlled effectiveness trial. Infect Control Hosp Epidemiol. 2010 Dec;31(12):1207-15. doi: 10.1086/657136. Epub 2010 Oct 28.
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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.
Timothy J Whitman, DO principal investigator
National Naval Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% chlorhexidine gluconate (CHG) impregnated cloths in people with Staphylococcus Aureus and Community-acquired Infections, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jul 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of skin and soft tissue infections among platoons enrolled in OCS. (time frame: May - Nov 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00475930, which also lists 1 linked publication.
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 17 Jul 2025.