Impact of Cleansing With Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-Drug Resistant Organisms (MDRO) in Children With Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT)
PRIMARY OBJECTIVES: I. To determine whether chlorhexidine gluconate (CHG) cleansing
decreases central line associated bloodstream infection (CLABSI) in children with cancer or
those receiving an allogeneic hematopoietic cell transplantation (HCT). SECONDARY
OBJECTIVES: I. To determine whether CHG cleansing decreases acquisition of multi-drug
resistant organisms [MDRO: vancomycin resistant enterococci (VRE), methicillin resistant
Staphylococcus aureus (MRSA), etc.] in children with cancer or those receiving allogeneic
HCT. II. To determine whether CHG cleansing in children with cancer or those receiving
allogeneic HCT is associated with cutaneous bacterial isolates with reduced susceptibility
to CHG. III. To determine whether CHG cleansing decreases positive blood cultures in
children with cancer or those receiving allogeneic HCT. OUTLINE: Patients are randomized to
1 of 2 arms. ARM I: Patients receive CHG cleansing with topical skin wipes once daily (QD)
for 90 days. ARM II: Patients receive control cleansing with topical skin wipes QD for 90
days.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Number of CLABSI events during the at-risk days
Estimated and compared between the 2 arms by a Poisson regression model adjusting for the randomization stratification factor on treatment/diagnosis.
Up to 90 days
No
Danielle Zerr
Principal Investigator
Children's Oncology Group
United States: Food and Drug Administration
ACCL1034
NCT01817075
June 2013
Name | Location |
---|---|
Children's Oncology Group | Arcadia, California 91006-3776 |