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. Cancer 2020;0:1-11.

Neutropenia and Infection Prophylaxis in Childhood Cancer

“…The trial was closed early secondary to low accrual and post-hoc analysis was conducted on the existing data. CHB did not reduce the rate of CLABSI in this patient population with 5.44 CLABSIs per 1000 central-line days in the CHB group compared with 3.10 in the control group (p = 0.049) [ 54 , 55 ]. In addition, 24% patients who used CHB had a cutaneous adverse event [ 55 ].…”

Reply to Are we certain that chlorhexidine gluconate bathing is not beneficial in deducing central line associated blood stream infections among children with cancer or undergoing hematopoietic stem cell transplantation?

“…Hord and Dandoy pointed to a potential imbalance of acute myeloid leukemia between randomized groups. It is for this reason that we performed a post hoc analysis adjusting for underlying disease as reported in our publication 1 . The estimated effect was similar after adjustments for the underlying diagnosis but was not statistically significant (see paragraph 2 of the Results section).…”

“…We appreciate the thoughtful comments provided by Hord and Dandoy regarding our article titled “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.” 1 The issues they raised and our responses follow below.…”

Are we certain that chlorhexidine gluconate bathing is not beneficial in reducing central line associated blood stream infections among children with cancer or undergoing hematopoietic stem cell transplantation?

“…As pediatric oncologists who both are members of the Children's Oncology Group (COG) and have devoted significant effort to reducing central line–associated bloodstream infections (CLABSIs) in children with cancer, we were excited in 2013 when the COG decided to study the impact of daily chlorhexidine gluconate (CHG) bathing on the incidence of CLABSIs in the pediatric oncology population. Before the opening of COG study ACCL1034, which was conducted under Zerr et al's direction, 1 the efficacy of CHG bathing in reducing CLABSIs had been demonstrated only in adults and critically ill children, and there were little data evaluating the impact of CHG bathing on CLABSIs specifically in pediatric oncology patients 2‐4 …”

“…Results from the aforementioned study were published in the October 20, 2020, issue of Cancer , 1 and on the basis of those results, the principal investigators concluded that the data “do not support the use of routine CHG bathing in children with cancer or those undergoing allogeneic HCT [hematopoietic stem cell transplantation].” After careful review of the publication, we have several concerns about the study and the conclusions that were drawn. First, in our clinical experience, most children with cancer in the United States complete their therapy with only an implanted tunneled catheter or port.…”