Chlorhexidine gluconate bathing in children with cancer or those undergoing hematopoietic stem cell transplantation: A double-blinded randomized controlled trial from the Children's Oncology Group

Abstract

Background: To the authors' knowledge, information regarding whether daily bathing with chlorhexidine gluconate (CHG) reduces central line-associated bloodstream infection (CLABSI) in pediatric oncology patients and those undergoing hematopoietic stem cell transplantation (HCT) is limited.

Methods: In the current multicenter, randomized, double-blind, placebo-controlled trial, patients aged ≥2 months and <22 years with cancer or those undergoing allogeneic HCT were randomized 1:1 to once-daily bathing with 2% CHG-impregnated cloths or control cloths for 90 days. The primary outcome was CLABSI. Secondary endpoints included total positive blood cultures, acquisition of resistant organisms, and acquisition of cutaneous staphylococcal isolates with an elevated CHG mean inhibitory concentration.

Results: The study was stopped early because of poor accrual. Among the 177 enrolled patients, 174 were considered as evaluable (88 were randomized to the CHG group and 86 were randomized to the control group). The rate of CLABSI per 1000 central line days in the CHG group was 5.44 versus 3.10 in the control group (risk difference, 2.37; 95% confidence interval, 0.05-4.69 [P = .049]). Post hoc conditional power analysis demonstrated a 0.2% chance that the results would have favored CHG had the study fully enrolled. The rate of total positive blood cultures did not differ between groups (risk difference, 2.37; 95% confidence interval, -0.41 to 5.14 [P = .078]). The number of patients demonstrating the new acquisition of resistant organisms did not differ between groups (P = .54). Patients in the CHG group were found to be more likely to acquire cutaneous staphylococcal isolates with an elevated CHG mean inhibitory concentration (P = .032).

Conclusions: The data from the current study do not support the use of routine CHG bathing in children with cancer or those undergoing allogeneic HCT.

Keywords: bacteremia; central line-associated bloodstream infection (CLABSI); chlorhexidine gluconate (CHG); multi-drug resistant organisms (MDRO).

Conflict of interest statement

Danielle M. Zerr has received grants from the National Institutes of Health for work performed as part of the current study. Aaron M. Milstone has received grants from Sage Products LLC and personal fees from Becton Dickinson for work performed outside of the current study. Amanda L. Adler has received grants from the National Institutes of Health for work performed as part of the current study. Lu Chen was supported by a Statistics and Data Center Grant from the National Cancer Institute for the Children's Oncology Group (COG) for work performed as part of the current study. Brian T. Fisher has received grants from Pfizer and Merck and has received personal fees from Astellas for serving on a Data Safety Monitoring Board for work performed outside of the current study. The other authors made no disclosures.

© 2020 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.

Figures

Figure 1

Consolidated Standards of Reporting Trials (CONSORT) diagram. CHG indicates chlorhexidine gluconate; AE, adverse event.

Figure 2

Cumulative incidence of time to first central line–associated bloodstream infection (CLABSI).

Figure 3

Organisms identified from positive blood cultures by infection category and treatment group. The size of the circles represents the number of events. BSI indicates bloodstream infection; CLABSI, central line–associated bloodstream infection; MBI, mucosal barrier injury.

Figure 4

Cutaneous adverse events and their attribution by treatment group.