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
NCT01817075 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177
Last updated 2021-06-22
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.
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
- 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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Children's Oncology Group
lead NETWORK
Principal Investigators
-
Danielle M Zerr · Children's Oncology Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Months
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-04
- Primary Completion
- 2019-03-31
- Completion
- 2020-03-31
Countries
- United States
- Canada
- Puerto Rico
Study Locations
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