A Double-blind Randomized Trial of Oral Chlorhexidine Gluconate for Treatment of Oral Staphylococcus aureus Colonization in Healthy Children

TY - JOUR

T1 - A Double-blind Randomized Trial of Oral Chlorhexidine Gluconate for Treatment of Oral Staphylococcus aureus Colonization in Healthy Children

AU - Liu, Lucia

AU - Launer, Bryn

AU - Flores, Evelyn

AU - Tchakalian, Greg

AU - Kreiswirth, Barry

AU - Bolaris, Michael

AU - Kim, Tae

AU - Young, Kelly D.

AU - Miller, Loren G.

N1 - Publisher Copyright: © The Author(s) 2026. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

PY - 2026/3

Y1 - 2026/3

N2 - Background: Staphylococcus aureus is the most common cause of skin and soft tissue infection (SSTI). Nasal S. aureus colonization may precede SSTI, and decolonization may decrease SSTI risk. However, many S. aureus–colonized persons are oropharyngeally colonized, sometimes without concomitant nasopharyngeal colonization. However, there are few data on oropharyngeal S. aureus decolonization, especially in children. Methods: We performed a prospective, double-blind, randomized controlled clinical trial of twice-daily 0.12% chlorhexidine gluconate (CHG) gargle vs a placebo for 7 days in healthy children oropharyngeally colonized with S. aureus. At each study visit (days 1, 8, 29), throat and nares cultures were performed. All S. aureus isolates underwent spa typing. Results: We screened 189 children, 120 (63%) of whom had S. aureus oropharyngeal colonization; of these, 67 (56%) were randomized. The median participant age was 11 years (mean, 11.7), and 27 (40%) were female. In the intention-to-treat population, oropharyngeal colonization at day 8 was 45% (15/33) and 79% (27/34) in the CHG and placebo groups, respectively (P = .004), and 61% (20/33) vs 85% (29/34) at day 29 (P = .03). Among children who were oropharyngeally decolonized at day 8 but positive for S. aureus at day 29, 8/12 (66%) exhibited a new spa type compared with baseline. Conclusions: We found that a 7-day 0.12% chlorhexidine gluconate mouthwash regimen significantly reduced S. aureus oropharyngeal colonization compared with placebo. This difference persisted at day 29, suggesting that CHG mouthwash may be a promising adjunctive decolonization agent that may decrease the high SSTI recurrence risk in children.

AB - Background: Staphylococcus aureus is the most common cause of skin and soft tissue infection (SSTI). Nasal S. aureus colonization may precede SSTI, and decolonization may decrease SSTI risk. However, many S. aureus–colonized persons are oropharyngeally colonized, sometimes without concomitant nasopharyngeal colonization. However, there are few data on oropharyngeal S. aureus decolonization, especially in children. Methods: We performed a prospective, double-blind, randomized controlled clinical trial of twice-daily 0.12% chlorhexidine gluconate (CHG) gargle vs a placebo for 7 days in healthy children oropharyngeally colonized with S. aureus. At each study visit (days 1, 8, 29), throat and nares cultures were performed. All S. aureus isolates underwent spa typing. Results: We screened 189 children, 120 (63%) of whom had S. aureus oropharyngeal colonization; of these, 67 (56%) were randomized. The median participant age was 11 years (mean, 11.7), and 27 (40%) were female. In the intention-to-treat population, oropharyngeal colonization at day 8 was 45% (15/33) and 79% (27/34) in the CHG and placebo groups, respectively (P = .004), and 61% (20/33) vs 85% (29/34) at day 29 (P = .03). Among children who were oropharyngeally decolonized at day 8 but positive for S. aureus at day 29, 8/12 (66%) exhibited a new spa type compared with baseline. Conclusions: We found that a 7-day 0.12% chlorhexidine gluconate mouthwash regimen significantly reduced S. aureus oropharyngeal colonization compared with placebo. This difference persisted at day 29, suggesting that CHG mouthwash may be a promising adjunctive decolonization agent that may decrease the high SSTI recurrence risk in children.

KW - Staphylococcus aureus

KW - chlorhexidine gluconate

KW - decolonization

KW - oropharyngeal colonization

KW - randomized clinical trial

UR - https://www.scopus.com/pages/publications/105041165210

U2 - 10.1093/ofid/ofag072

DO - 10.1093/ofid/ofag072

M3 - Article

SN - 2328-8957

VL - 13

JO - Open Forum Infectious Diseases

JF - Open Forum Infectious Diseases

IS - 3

ER -