Recent Updates
Recently added Catalysts

2% Chlorhexidine gluconate cloth

Phase 2

Nosocomial Infections | Small molecule | Infectious Disease |Sage Therapeutics, Inc.|Last Updated: Jun 14, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment5,659

FDA Designations

No designations recorded

Clinical trial landscape

2% Chlorhexidine gluconate cloth · 1 trial · 1 indication

Phase 2 1
NCT00549393Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care UnitNosocomial Infections
COMPLETED5,659 Analytics
PHASE2COMPLETED
Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Nosocomial InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Bacteremia
participants were followed for the duration of ICU stay, median stay 3 days

incidence of bacteremia comparing those in treatment and control groups

Secondary Endpoints

Central Line Associated-bloodstream Infection (CLABSI)
participants were followed for the duration of ICU stay, median stay 3 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDaily bathing with 2% chlorhexidine gluconate
2NO_INTERVENTIONStandard bathing with soap and water basin or disposable cloth

Interventions

NameTypeDescription
2% Chlorhexidine gluconate clothDRUGDaily bathing
Unlock Study Design Details

Eligibility Criteria

Age Range2 Months to 25 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients in pediatric intensive care unit Exclusion Criteria: * Patients with a history of an allergic reaction to chlorhexidine * Patients less than 2 months of age * Patients with severe skin disease or burn * Patients with an indwelling epidural catheter or lumbar drain

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about 2% Chlorhexidine gluconate cloth

What is 2% Chlorhexidine gluconate cloth used for?

2% Chlorhexidine gluconate cloth is used for nosocomial infections, which are infections acquired in a healthcare setting. It is being studied as a bathing intervention to reduce these infections in pediatric intensive care unit patients. The drug is in Phase 2 clinical development and is not yet approved.

Who makes 2% Chlorhexidine gluconate cloth?

Sage Therapeutics, Inc. (NASDAQ: SAGE) is developing 2% Chlorhexidine gluconate cloth. The company is conducting clinical research on this product for the prevention of nosocomial infections in pediatric intensive care unit patients.

What phase is 2% Chlorhexidine gluconate cloth in?

2% Chlorhexidine gluconate cloth is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the product is not currently in active clinical trials.

What clinical trials is 2% Chlorhexidine gluconate cloth in?

2% Chlorhexidine gluconate cloth has one completed clinical trial, NCT00549393, titled "Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit." This Phase 2 trial enrolled 5,659 participants in the United States and was not blinded.

How does 2% Chlorhexidine gluconate cloth work?

2% Chlorhexidine gluconate cloth is a small molecule antiseptic. It works by reducing bacteria on the skin through bathing, which may help prevent nosocomial infections in hospitalized patients. The cloth delivers chlorhexidine gluconate to the skin surface during patient bathing.

Is 2% Chlorhexidine gluconate cloth FDA approved?

2% Chlorhexidine gluconate cloth is not FDA approved. It is an investigational product currently in Phase 2 clinical development. The completed trial NCT00549393 studied its use in pediatric intensive care unit patients, but the product has not received regulatory approval.