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2% chlorhexidine gluconate impregnated cloth

Phase 1

Nosocomial Infection | Small molecule | Infectious Disease |Sage Therapeutics, Inc.|Last Updated: Jun 18, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment208

FDA Designations

No designations recorded

Clinical trial landscape

2% chlorhexidine gluconate impregnated cloth · 1 trial · 6 indications

Phase 1 1
NCT00130221Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired InfectionsNosocomial Infection
COMPLETED208 Analytics
PHASE1COMPLETED
Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections
Nosocomial InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical: Primary blood stream infections and culture negative sepsis
Six Months

Weekly culture of central line insertion sites

Microbiologic: Skin colonization from environment and endotracheal secretions
Six Months

Weekly skin cultures

Secondary Endpoints

Clinical: Laboratory confirmed blood stream infections
Six months
Nosocomial infections
Six months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
chlorhexidine gluconate (CHG)EXPERIMENTALdaily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage)
Soap & WaterACTIVE_COMPARATORbathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths

Interventions

NameTypeDescription
2% chlorhexidine gluconate impregnated clothDRUG -
Daily bathing with Bar soapOTHERbathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Data collection will be compiled from all the participants admitted to the Medical Intensive Care Unit (MICU). * For skin cultures: One randomly selected (intubated or non-intubated) patient in each intervention group Exclusion Criteria: * Patients with greater than 20% of b...

Countries:United States
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Frequently asked questions about 2% chlorhexidine gluconate impregnated cloth

What is 2% chlorhexidine gluconate impregnated cloth used for?

2% chlorhexidine gluconate impregnated cloth is used for the prevention of nosocomial infections, which are hospital-acquired infections. It is being studied for conditions including bacteremia, sepsis, pneumonia, urinary tract infection, and Clostridium infection. The cloth is applied to the skin for cleansing purposes in a clinical setting.

Who makes 2% chlorhexidine gluconate impregnated cloth?

Sage Therapeutics, Inc. (NASDAQ: SAGE) is the developer of 2% chlorhexidine gluconate impregnated cloth. The company is conducting clinical research on this product for the prevention of nosocomial infections.

What phase is 2% chlorhexidine gluconate impregnated cloth in?

2% chlorhexidine gluconate impregnated cloth is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is 2% chlorhexidine gluconate impregnated cloth in?

2% chlorhexidine gluconate impregnated cloth has one completed clinical trial, NCT00130221, titled "Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections." This Phase 1 trial enrolled 208 participants in the United States and was active-controlled, meaning it compared the cloth against another treatment.

Is 2% chlorhexidine gluconate impregnated cloth the same as chlorhexidine gluconate?

2% chlorhexidine gluconate impregnated cloth is a specific formulation of chlorhexidine gluconate, where the active ingredient is impregnated into a cloth for topical application. It is being studied for its ability to reduce hospital-acquired infections through skin cleansing.