NCT01817075

Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 2 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant organisms in younger patients with cancer or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream infections and bacterial infections associated with the central line.

Detailed description

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.

Conditions

• Bacterial Infection
• Benign Neoplasm
• Malignant Neoplasm
• Methicillin-Resistant Staphylococcus Aureus Infection
• Myeloid Neoplasm
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	Chlorhexidine Gluconate Skin Cleanser	Given CHG cleansing
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Mild Soap Skin Cleanser	Given control cleansing
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2013-11-04
• Primary completion: 2019-03-31
• Completion: 2020-03-31
• First posted: 2013-03-22
• Last updated: 2021-06-22
• Results posted: 2020-04-08

Locations

59 sites across 3 countries: United States, Canada, Puerto Rico