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

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 versus a placebo for 7 days in healthy children oropharyngeally colonized with S. aureus. At each study visit (Day 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. 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=0.004), and 61% (20/33) vs. 85% (29/34) at Day 29 (P=0.03). 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 to baseline. Conclusions We found that a 7-day 0.12% chlorhexidine gluconate mouthwash regimen significantly reduced S. aureus oropharyngeal colonization compared to 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.